Bone graft delivery system and method for using same

ABSTRACT

The present invention relates to an apparatus and method for near-simultaneous and integrated delivery of bone graft material during the placement of surgical cages or other medical implants in a patient&#39;s spine. The integrated fusion cage and graft delivery device according to various embodiments delivers and disperses biologic material through a fusion cage to a disc space and, without withdrawal from the surgical site, may selectively detach the fusion cage for deposit to the same disc space. The integrated fusion cage and graft delivery device is formed such that a hollow tube and plunger selectively and controllably place bone graft material and a fusion cage in or adjacent to the bone graft receiving area. In one embodiment, the integrated fusion cage is an expandable integrated fusion cage. In another embodiment, the bone graft material is loaded into a breech area in the hollow tube.

RELATED APPLICATION

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 62/900,960, filed Sep. 16, 2019, the entire disclosure of whichis hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

This disclosure relates to orthopedic surgery, and more specifically toan apparatus and method for near-simultaneous and integrated delivery ofbone graft material during the placement of surgical cages or othermedical implants in a patient's spine.

BACKGROUND OF THE INVENTION

Individuals who suffer degenerative disc disease, natural spinedeformations, a herniated disc, spine injuries or other spine disordersmay require surgery on the affected region to relieve the individualfrom pain and prevent further injury to the spine and nerves. Spinalsurgery may involve removal of damaged joint tissue, insertion of atissue implant and/or fixation of two or more adjacent vertebral bodies.In some instances, a medical implant is also inserted, such as a fusioncage. The surgical procedure will vary depending on the nature andextent of the injury. Generally, there are five main types of lumbarfusion, including: posterior lumbar fusion (“PLF”), posterior lumbarinterbody fusion (“PLIF”), anterior lumbar interbody fusion (“ALIF”),circumferential 360 fusion, and transforaminal lumbar interbody fusion(“TLIF”). More recently, direct lateral interbody fusion (“D-LIF”) hasbecome available. A posterior approach is one that accesses the surgicalsite from the patient's back, an anterior approach is one that accessesthe surgical site from the patient's front or chest, and a directlateral approach is one that accesses the surgical site from thepatient's side. There are similar approaches for fusion in the interbodyor cervical spine regions. For a general background on some of theseprocedures and the tools and apparatus used in certain procedures, seeU.S. Prov. Pat. Appl. No. 61/120,260 filed on Dec. 5, 2008, the entiredisclosure of which is incorporated by reference in its entirety. Inaddition, further background on procedures and tools and apparatus usedin spinal procedures is found in U.S. patent application Ser. No.12/632,720 filed on Dec. 7, 2009, now U.S. Pat. No. 8,366,748, theentire disclosure of which is incorporated by reference in its entirety.

Vertebrectomy, or the removal or excision of a vertebra, is another typeof spinal surgery that may be necessary to alleviate pain and/or correctspinal defects, such as when disk material above and below a particularvertebra protrudes from the spine and contacts the spinal cord. Once theproblematic vertebra is removed, a specialized fusion cage (also calleda vertebrectomy cage) may be inserted into its place to restorestructural continuity to the spine.

Some disadvantages of traditional methods of spinal surgery include, forexample, the pain associated with the procedure, the length of theprocedure, the complexity of implements used to carry out the procedure,the prolonged hospitalization required to manage pain, the risk ofinfection due to the invasive nature of the procedure, and the possiblerequirement of a second procedure to harvest autograft bone from theiliac crest or other suitable site on the patient for generating therequired quantity of cancellous and/or cortical bone.

A variety of semisolid bone graft materials are available on the marketwhich ostensibly increase spinal fusion rates without the morbidity ofautograft bone harvest. Each of the manufacturers espouses their productas the most advantageous for healing. These products all have similarhandling characteristics and the literature reveals that they havesimilar healing prospects. They come in a syringe and it is up to thesurgeon to apply the selected material to the target site. The mostcommon site for application is to the disk space after it has beenprepared to a bleeding bed and ready to accept a cage and/or thegrafting material. This represents a long and narrow channel even inopen procedures. The surgeon is left to his own devices as to how to getthe graft from its container to the active site. The devices which havebeen used have included a “caulking gun” construct and a variety ofbarrel shaft with a plunger design.

Bone graft typically includes crushed bone (cancellous and cortical), ora combination of these (and/or other natural materials), and may furthercomprise synthetic biocompatible materials. Bone graft of this type isintended to stimulate growth of healthy bone. As used herein, “bonegraft” shall mean materials made up entirely of natural materials,entirely of synthetic biocompatible materials, or any combination ofthese materials. Bone graft often is provided by the supplier in a gelor slurry form, as opposed to a dry or granule form. Many companiesprovide various forms of bone graft in varying degrees of liquidity andviscosity, which may cause problems in certain prior art deliverydevices in both prepackaged or packaged by the surgeon embodiments. Inaddition, the method of delivery of bone graft to a particular locationvaries depending on the form of the bone graft utilized.

Autogenous bone (bone from the patient) or allograft bone (bone fromanother individual) are the most commonly used materials to induce boneformation. Generally, small pieces of bone are placed into the spacebetween the vertebrae to be fused. Sometimes larger solid pieces of boneare used to provide immediate structural support. Autogenous bone isgenerally considered superior at promoting fusion. However, thisprocedure requires extra surgery to remove bone from another area of thepatient's body such as the pelvis or fibula. Thus, it has been reportedthat about 30 percent of patients have significant pain and tendernessat the graft harvest site, which may be prolonged, and in some casesoutlast the back pain the procedure intended to correct. Similarly,allograft bone and other bone graft substitutes, although eliminatingthe need for a second surgery, have drawbacks in that they have yet tobe proven as cost effective and efficacious substitutes for autogenousbone fusion.

An alternative to autogenous or allograft bone is the use of growthfactors that promote bone formation. For example, studies have shownthat the use of bone morphogenic proteins (“BMPs”) results in betteroverall fusion, less time in the operating room and, more importantly,fewer complications for patients because it eliminates the need for thesecond surgery. However, use of BMPs, although efficacious in promotingbone growth, can be prohibitively expensive.

Another alternative is the use of a genetically engineered version of anaturally occurring bone growth factor. This approach also haslimitations. Specifically, surgeons have expressed concerns thatgenetically engineered BMPs can dramatically speed the growth ofcancerous cells or cause non-cancerous cells to become more sinister.Another concern is unwanted bone creation. There is a chance that bonegenerated by genetically engineered BMPs could form over the delicatenerve endings in the spine or, worse, somewhere else in the body.

Many different methods and approaches have been attempted to induce boneformation or to promote spinal fusion. The traditional devices forinserting bone graft impair the surgeon's visualization of the operativesite, which can lead to imprecise insertion of bone graft and possibleharm to the patient. The caulking gun and the collection of largebarrel/plunger designs typically present components at the top of theirstructure which block the view of the surgical site. The surgeon mustthen resort to applying pressure to the surgical site to approximate thelocation of the device's delivery area. Such rough maneuvering canresult in imprecise placement of bone graft, and in some cases, ruptureof the surgical area by penetrating the annulus and entering theabdominal cavity. Also, in some surgical procedures, the devices forinserting bone graft material are applied within a cannula inserted orplaced in the surgical area, further limiting the size and/or profile ofthe bone graft insertion device. When a cannula is involved, sometraditional devices such as the large barrel/plunger designs and/or thecaulking gun designs simply cannot be used as they cannot be insertedwithin the cannula.

Traditional devices for inserting bone graft deliver the bone graftmaterial at the bottom of the delivery device along the device'slongitudinal axis. Such a delivery method causes the bone graftingmaterial to become impacted at the bottom of the delivery device whichjams the device and promotes risk of rupture of the surgical area bypenetrating the annulus and entering the abdominal cavity. Further,traditional devices that deliver bone graft material along theirlongitudinal axis may cause rupture of the surgical area or harm to thepatient because of the ensuing pressure imparted by the ejected bonegraft material from the longitudinal axis of the device. Furthermore,the graft material is distributed only in the longitudinal axis and doesnot fill in the peripheral areas of the disk.

Traditional devices for inserting a fusion cage or other medicalimplants into a patient's spine or other surgical area are distinct andseparate from traditional devices that deliver bone graft material tothe surgical site. For example, once an implant has been positioned,then bone growth material is packed into the internal cavity of thefusion cage. Also, sometimes the process is reversed, i.e., the bonegrowth is inserted first, and then the implant. These bone growthinducing substances come into immediate contact with the bone from thevertebral bone structures which project into the internal cavity throughthe apertures. Two devices are thus traditionally used to insert bonegraft material into a patient's spine and to position and insert afusion cage. These devices thus necessitate a disc space preparationfollowed by introduction of the biologic materials necessary to inducefusion and, in a separate step, application of a structural interbodyfusion cage.

The problems associated with separate administration of the biologicmaterial bone graft material and the insertion of a fusion cage includeapplying the graft material in the path of the cage, restricting andlimiting the biologic material dispersed within the disk space, andrequiring that the fusion cage be pushed back into the same place thatthe fusion material delivery device was, which can lead to additionaltrauma to the delicate nerve structures.

Fusion cages provide a space for inserting a bone graft between adjacentportions of bone. Such cages are often made of titanium and are hollow,threaded, and porous in order to allow a bone graft contained within theinterior of the cage of grow through the cage into adjacent vertebralbodies. Such cages are used to treat a variety of spinal disorders,including degenerative disc diseases such as Grade I or IIspondylolistheses of the lumbar spine.

Surgically implantable intervertebral fusion cages are well known in theart and have been actively used to perform spinal fusion procedures formany years. Their use became popularized during the mid-1990's with theintroduction of the BAK Device from the Zimmer Inc., a specificintervertebral fusion cage that has been implanted worldwide more thanany other intervertebral fusion cage system. The BAK system is afenestrated, threaded, cylindrical, titanium alloy device that iscapable of being implanted into a patient as described above through ananterior or posterior approach, and is indicated for cervical and lumbarspinal surgery. The BAK system typifies a spinal fusion cage in that itis a highly fenestrated, hollow structure that will fit between twovertebrae at the location of the intervertebral disc.

Spinal fusion cages may be placed in front of the spine, a procedureknown as anterior lumbar interbody fusion, or ALIF, or placed in back ofthe spine. The cages are generally inserted through a traditional openoperation, though laparoscopic or percutaneous insertion techniques mayalso be used. Cages may also be placed through a posterior lumbarinterbody fusion, or PLIF, technique, involving placement of the cagethrough a midline incision in the back, or through a direct lateralinterbody fusion, or D-LIF, technique, involving placement of the cagethrough an incision in the side.

A typical procedure for inserting a common threaded and impacted fusioncage is as follows. First, the disc space between two vertebrae of thelumbar spine is opened using a wedge or other device on a first side ofthe vertebrae. The disk space is then prepared to receive a fusion cage.Conventionally, a threaded cage is inserted into the bore and the wedgeis removed. A disk space at the first side of the vertebrae is thenprepared, and a second threaded fusion cage inserted into the bore.Alternatively, the disk space between adjacent vertebrae may simply becleared and a cage inserted therein. Often, only one cage is insertedobliquely into the disk space. Use of a threaded cage may be foregone infavor of a rectangular or pellet-shaped cage that is simply insertedinto the disk space. Lastly, bone graft material may be inserted intothe surgical area using separate tools and devices.

Traditional fusion cages are available in a variety of designs andcomposed of a variety of materials. The cages or plugs are commonly madeof an inert metal substrate such as stainless steel,cobalt-chromium-molybdenum alloys, titanium or the like having a porouscoating of metal particles of similar substrate metal, preferablytitanium or the like as disclosed, for example, in the Robert M. PilliarU.S. Pat. No. 3,855,638 issued Dec. 24, 1974 and U.S. Pat. No. 4,206,516issued Jun. 10, 1980. These plugs may take the form of flat sidedcubical or rectangular slabs, cylindrical rods, cruciform blocks, andthe like.

Prior art bone graft delivery devices typically must come pre-loadedwith bone graft, or alternatively require constant loading (wherepermissible) in order to constantly have the desired supply of bonegraft available. Moreover, these bone graft delivery devices generallycannot handle particulate bone graft of varying or irregular particulatesize. Furthermore, the prior art devices for inserting a fusion cage orother medical implant into a patient's spine or other surgical area arecommonly distinct and separate from traditional devices that deliverbone graft material to the surgical site. As such, two devices aretraditionally used to insert bone graft material into a patient's spineand to position and insert a fusion cage. The problems associated withseparate administration of the biologic material bone graft material andthe insertion of a fusion cage include applying the graft material inthe path of the cage, restricting and limiting the biologic materialdispersed within the disk space, and requiring that the fusion cage bepushed back into the same place that the fusion material delivery devicewas, which can lead to additional trauma to the delicate nervestructures. These problems can be a great inconvenience, cause avoidabletrauma to a patient and make these prior art devices unsuitable in manyprocedures.

Therefore, there is a long-felt need for an apparatus and method fornear-simultaneous and integrated precision delivery of bone graftmaterial during the placement of surgical cages or other medicalimplants in a patient's spine. The present invention solves these needs.The present invention allows biologic material to flow directly to thefusion cage and be dispersed within the disc space in a single step, andcan precisely and simply deliver particulate bone graft of varying orirregular particulate size. Thus, the present invention allowsapplication of bone graft material through a detachable fusion cage,eliminates otherwise restriction of the volume of biologic material thatmay be dispersed within the disk space, and eliminates the requirementthat the fusion cage be pushed back into the same place that the fusionmaterial delivery device was, which can lead to additional trauma to thedelicate nerve structures.

SUMMARY OF THE INVENTION

It is one aspect of the present invention to provide a bone graftmaterial delivery system, comprising a hollow tube adapted to receivebone graft material, the hollow tube having a proximal portion; a distalportion with at least one opening therein; a breech area interconnectedto at least one of the proximal portion and the distal portion via abreech hinge, and configured to rotate about the breech hinge between anopen position and a closed position; and a means for urging bone graftmaterial from the proximal portion through the distal portion andoutwardly through the at least one opening of the distal portion,wherein the proximal portion is securely interconnected to the distalportion along a longitudinal axis of the hollow tube, and wherein, whenthe breech area is in the open position, an interior volume of theproximal portion is exposed to allow for loading of bone graft materialtherein.

In embodiments, the secure interconnection between the proximal portionand the distal portion may comprise an ultraviolet light-activatedadhesive.

In embodiments, the at least one opening may comprise two openings onlateral sides of the hollow tube.

In embodiments, the means for urging may comprise a plunger. The plungermay, but need not, have teeth formed along a longitudinal axis of theplunger. At least a portion of the hollow tube may, but need not, begenerally transparent such that the plunger is at least partiallyvisible within the hollow tube. One or more of the hollow tube and theplunger may, but need not, be printed using a three-dimensional printingprocess, wherein the three-dimensional printing process comprises one ormore of fused filament fabrication, plaster-based three-dimensionalprinting, selective laser sintering, selective heat sintering, anddirect ink writing. The bone graft material delivery system may, butneed not, further comprise a pivotally mounted trigger configured toengage the teeth of the plunger, wherein the pivotally mounted triggeris operable to advance the plunger toward the distal end of the hollowtube.

In embodiments, the distal end of the hollow tube may comprise a bulletshaped distal tip.

In embodiments, the distal end of the hollow tube may be at leastpartially closed.

In embodiments, the hollow interior of the hollow tube may have agenerally rectangular cross-section.

In embodiments, the hollow tube may be generally linear.

In embodiments, the hollow tube may be flexible.

In embodiments, the bone graft material delivery system may furthercomprise a funnel configured to be coupled to the proximal end of thehollow tube.

In embodiments, the bone graft material delivery system may furthercomprise a syringe configured to be coupled to the hollow tube, whereinthe bone graft material is mixed within the syringe and subsequentlyconveyed into the hollow interior of the hollow tube.

In embodiments, the bone graft material delivery system may furthercomprise a fusion cage detachably coupled to the distal end of thehollow tube.

In embodiments, the bone graft material delivery system may furthercomprise a breech lock mechanism, configured to selectively lock thebreech area in the closed position. The breech lock mechanism may, butneed not, be spring-loaded.

In embodiments, the proximal portion of the hollow tube may comprise avertically extending rail configured to snugly mate with the breech areawhen the breech area is in the closed position.

In embodiments, the distal portion of the hollow tube may comprise aknuckle and at least one of the proximal portion and the breech areacomprises a cavity, wherein the knuckle mates with and snugly fitswithin the cavity when the breech area is in the closed position.

In an another aspect, a bone graft material delivery system is provided,and includes a hollow tube adapted to receive bone graft material, thehollow tube having a proximal portion, a distal portion with at leastone opening therein and a breech area interconnected to at least one ofthe proximal portion and the distal portion via a breech hinge, andconfigured to rotate about the breech hinge between an open position anda closed position. The system also includes a plunger configured forurging bone graft material from the proximal portion through the distalportion and outwardly through the at least one opening of the distalportion, wherein the proximal portion is securely interconnected to thedistal portion along a longitudinal axis of the hollow tube, andwherein, when the breech area is in the open position, an interiorvolume of the proximal portion is exposed to allow for loading of bonegraft material therein.

In another aspect, a method for delivering a bone graft material to anarea within a patient is provided. The method includes the steps ofproviding a hollow tube having a proximal portion, a distal portion withat least one opening therein, and a breech area interconnected to atleast one of the proximal portion and the distal portion via a breechhinge, and configured to rotate about the breech hinge between an openposition and a closed position, the hollow tube being adapted to receivebone graft material therein; positioning the distal end within thepatient's area; positioning the breech hinge in the open position;loading the bone graft material into the breech area; and urging bonegraft material through the hollow tube from the proximal portion to thedistal portion and outwardly through the at least one opening of thedistal portion, whereby the bone graft material is introduced throughthe at least one opening into the patient's area.

In another aspect, a bone graft material delivery kit is provided. Thekit includes a hollow tube having a proximal portion, a distal portionwith at least one opening therein, and a breech area interconnected toat least one of the proximal portion and the distal portion via a breechhinge, and configured to rotate about the breech hinge between an openposition and a closed position, the hollow tube being adapted to receivebone graft material therein. The kit also includes a plunger configuredfor urging bone graft material from the proximal portion through thedistal portion and outwardly through the at least one opening of thedistal portion. In various embodiments, the kit may include additionalelements, such as an implant.

Certain embodiments of the present disclosure relate to an apparatus andmethod for near-simultaneous and integrated delivery of bone graftmaterial during the placement of surgical cages or other medicalimplants in a patient's spine. The integrated fusion cage and deliverydevice (the “device”) is comprised generally of a tubular member and aplunger for expelling bone graft from the tubular member, through asurgical fusion cage, and into a bone graft receiving area, thendisengaging the fusion cage at the surgical site in a human patient.Thus, the apparatus and method allows the biologic material to flowdirectly into and through the fusion cage and be dispersed within thedisc space in a single step, and leave the detachable fusion cage in thesurgical area. In one embodiment, the integrated fusion cage is anexpandable integrated fusion cage. Other embodiments and alternatives tothis device are described in greater detail below.

By way of providing additional background, context, and to furthersatisfy the written description requirements of 35 U.S.C. § 112, thefollowing references are incorporated by reference in their entiretiesfor the express purpose of explaining the nature of the surgicalprocedures in which bone graft is used and to further describe thevarious tools and other apparatus commonly associated therewith: U.S.Pat. No. 6,309,395 to Smith et al.; U.S. Pat. No. 6,142,998 to Smith etal.; U.S. Pat. No. 7,014,640 to Kemppanien et al.; U.S. Pat. No.7,406,775 to Funk, et al.; U.S. Pat. No. 7,387,643 to Michelson; U.S.Pat. No. 7,341,590 to Ferree; U.S. Pat. No. 7,288,093 to Michelson; U.S.Pat. No. 7,207,992 to Ritland; U.S. Pat. No. 7,077,864 Byrd III, et al.;U.S. Pat. No. 7,025,769 to Ferree; U.S. Pat. No. 6,719,795 to Cornwall,et al.; U.S. Pat. No. 6,364,880 to Michelson; U.S. Pat. No. 6,328,738 toSuddaby; U.S. Pat. No. 6,290,724 to Marino; U.S. Pat. No. 6,113,602 toSand; U.S. Pat. No. 6,030,401 to Marino; U.S. Pat. No. 5,865,846 toBryan, et al.; U.S. Pat. No. 5,569,246 to Ojima, et al.; U.S. Pat. No.5,527,312 to Ray; and U.S. Pat. Appl. Pub. No. 2008/0255564 toMichelson.

By way of providing additional background, context, and to furthersatisfy the written description requirements of 35 U.S.C. § 112, thefollowing references are incorporated by reference in their entiretiesfor the express purpose of explaining the nature of the surgicalprocedures in which fusion cages are used and to further describe thevarious tools and other apparatus commonly associated therewith: U.S.Pat. No. 6,569,201 to Moumene et al.; U.S. Pat. No. 6,159,211 to Borianiet al.; U.S. Pat. No. 4,743,256 to Brantigan; U.S. Pat. Appl.2007/0043442 to Abernathie et al.; U.S. Pat. Nos. 3,855,638 and4,206,516 to Pilliar; U.S. Pat. No. 5,906,616 issued to Pavlov et al.;U.S. Pat. No. 5,702,449 to McKay; U.S. Pat. No. 6,569,201 to Moumene etal.; PCT Appl. No. WO 99/08627 to Gresser; U.S. Pat. Appl. Pub.2012/0022651 to Akyuz et al.; U.S. Pat. Appl. Pub. 2011/0015748 to Molzet al.; U.S. Pat. Appl. Pub. 2010/0249934 to Melkent; U.S. Pat. Appl.Pub. 2009/0187194 to Hamada; U.S. Pat. No. 7,867,277 issued to Tohmeh;U.S. Pat. No. 7,846,210 to Perez-Cruet et al.; U.S. Pat. No. 7,985,256issued to Grotz et al.; U.S. Pat. Appl. Pub. 2010/0198140 to Lawson; andU.S. Pat. Appl. Pub. 2010/0262245 to Alfaro et al.

By way of providing additional background and context, the followingreferences are also incorporated by reference in their entireties forthe purpose of explaining the nature of spinal fusion and devices andmethods commonly associated therewith: U.S. Pat. No. 7,595,043 issued toHedrick et al.; U.S. Pat. No. 6,890,728 to Dolecek et al.; U.S. Pat. No.7,364,657 to Mandrusov, and U.S. Pat. No. 8,088,163 to Kleiner.

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No. 2010/0331847 entitled “Methods and Apparatus forPerforming Knee Arthroplasty” to Wilkinson, et al., issued Dec. 30,2010; U.S. Pat. Appl.

Pub. No. 2006/0116770 entitled “Vertebral Body and Disc SpaceReplacement Devices” to White, et al., issued Jun. 1, 2006; and U.S.Pat. No. 8,246,572 entitled “Bone Graft Applicator” to Cantor, et al.,issued Aug. 21, 2012.

According to varying embodiments described herein, the present inventionis directed to near-simultaneous and integrated delivery of bone graftmaterial during the placement of surgical cages or other medicalimplants into a patient's spine. The delivery of the bone graft materialmay be to any area of the body, and in particular, to the intervertebraljoints of the spine, for achieving bone graft fusion. The device may beused without the optional near-simultaneous and integrated placement ofsurgical cages with the delivery of bone graft material. Also, theinvention may be used in the repair of a bone joint or in connectionwith the implantation of prosthetic devices in the body, including, byway of example but not limitation, the hip, knee and a variety of spinaljoints. Additionally, the present invention may be used in primarysurgery, in which a bone graft is being supplied to promote new bonegrowth or to reconstruct a joint for the first time, as well as inrevision surgery, in which a follow-up procedure is being performed inan area that has previously been subject to one or more surgeries.Further, the invention may be used in any application where material isto be delivered with precision to a confined area where access isrestricted, to include surgical procedures, repair of installed oruninstalled mechanical or electrical devices, and arming or disarming ofexplosive devices.

Although well suited for use in human patients, and although much of thediscussion of the present invention is directed toward use in humans,advantages offered by the present invention may be realized in theveterinary and scientific fields for the benefit and study of all typesof animals and biological systems. Additionally, although the fusioncages of the present invention are particularly well-suited forimplantation into the spinal column between two target vertebrae, andalthough much of the discussion of the present invention is directedtoward their use in spinal applications, advantages offered byembodiments of the present invention may also be realized byimplantation at other locations within a patient where the fusion of twoor more bony structures may be desired. As one of skill in the art willappreciate, the present invention has applications in the general fieldof skeletal repair and treatment, with particular application to thetreatment of spinal injuries and diseases. It should be appreciated,however that the principles of the present invention can also findapplication in other areas, specifically where there is a desire toconstrain added fluid material to particular regions. For example, thepresent invention finds application in methods where the objective is toconfine added material to predetermined areas of interest and toprohibit the undesired translocation of such material until an operationis complete and/or until a predetermined later time.

One aspect of the present disclosure is a bone graft material deliverysystem.

The system includes, but is not limited to: (1) a hollow tube to receivebone graft material, the hollow tube having: (a) a proximal end; (b) adistal end with at least one opening; (c) a hollow interior from theproximal end to the distal end; and (d) at least one vent port; and (2)a plunger adapted to be inserted into the hollow tube. The plungerincludes a distal end with an exterior surface contoured to form asubstantially congruent fit with the hollow interior of the hollow tube.The hollow tube and the plunger are configured to deliver bone graftmaterial through the at least one opening in the distal end.

The at least one vent port is positioned between the proximal end andthe distal end of the hollow tube. In one embodiment, the at least onevent port has at least one of a size and a shape to prevent passage ofthe bone graft material through the at least one vent port.Additionally, the at least one vent port is configured to permit air tobe released from the hollow interior of the hollow tube. Optionally, theat least one vent port comprises a proximal vent port, a medial ventport, and a distal vent port. In one embodiment, the at least one ventport has a shape that is generally circular or generally linear.Additionally, or alternatively, in one embodiment, the at least one ventport has a width of less than approximately 2 mm.

In one embodiment, the hollow tube comprises a first portioninterconnected to a second portion. Optionally, the first portion issonically welded to the second portion. In another embodiment, the firstportion is glued to the second portion. The glue may comprise anadhesive that is activated by ultraviolet light. Other suitable gluesand adhesives may be used with the system of the present disclosure.

In one embodiment, the distal end of the hollow tube is configured toengage a fusion cage such that the bone graft material is deliveredthrough an opening of the fusion cage. Additionally, or alternatively,the at least one opening may comprise two openings.

Optionally, the two openings may be positioned on lateral sides of thehollow tube.

In one embodiment, the system further comprises a means for advancingthe plunger within the hollow interior towards the distal end of thehollow tube. The means for advancing may optionally include notches orteeth formed in the plunger. The teeth may be formed along alongitudinal axis of the plunger.

In one embodiment, the means for advancing includes a ratchet or a gearconfigured to engage the teeth of the plunger. Optionally, the means foradvancing includes a trigger associated with the ratchet, the triggeroperable to advance the plunger toward the distal end of the hollowtube. Additionally, or alternatively, the means for advancing mayinclude a knob associated with the gear. In one embodiment, the gearincludes teeth such that when the knob is rotated, the gear teethinteract with the plunger teeth to advance the plunger toward the distalend of the hollow tube.

In one embodiment, the means for advancing comprises a manual forceapplied by an operator. In another embodiment the means for advancingcomprises an electric motor. The electric motor can be associated withthe gear. In one embodiment, the gear includes teeth such that when themotor rotates the gear, the gear teeth interact with the plunger teethto advance the plunger toward the distal end of the hollow tube.

The system may further comprise a pivotally mounted trigger configuredto engage the teeth of the plunger. The pivotally mounted trigger isoperable to advance the plunger toward the distal end of the hollowtube.

In one embodiment, the distal end of the hollow tube comprises a roundedor bullet shape. Optionally, at least a portion of the distal end isclosed. In one embodiment, the distal end of the hollow tube is at leastpartially closed. Additionally, or alternatively, at least a portion ofthe distal end may include an opening.

In one embodiment, the hollow interior of the hollow tube has agenerally rectangular interior cross-section. Alternatively, in anotherembodiment, the hollow interior of the hollow tube has a generallycircular interior cross-section. In one embodiment, the hollow tube isgenerally linear.

Alternatively, in another embodiment, the distal end may be orientedtransverse to the proximal end. Additionally, or alternatively, thehollow tube may be flexible. In one embodiment, at least a portion ofthe hollow tube is generally transparent or translucent. In this manner,the plunger is at least partially visible within the hollow tube.

The system may further include one or more of an endoscope and a cameraassociated with the hollow tube. In one embodiment, the endoscope and/orthe camera may be positioned outside of the hollow tube. In anotherembodiment, the endoscope and/or the camera may be positioned within atleast a portion of the hollow interior of the hollow tube.

In one embodiment the system further includes a funnel interconnectableto the hollow tube. Accordingly, the proximal end of the hollow tube maybe configured to releasably couple to the funnel.

Optionally, the hollow tube is configured to couple to a syringe. Thus,the system may further comprise a syringe interconnectable to the hollowtube. In one embodiment, the bone graft material is mixed within thesyringe and subsequently conveyed into the hollow interior of the hollowtube.

The hollow tube and the plunger may be made of a variety of materialsincluding one or more of a metal, polyether ether ketone (PEEK),polyether ketone ether ketone (“PEKEKK”), other plastics, andcombinations thereof.

In one embodiment, one or more elements of the system, such as thehollow tube and the plunger, are manufactured by a three-dimensionalprinting process. A “three-dimensional printing process,” as usedherein, refers to any of a variety of additive manufacturing processesfor making a three-dimensional object based on a three-dimensional modelor electronic source input under computer control. Three-dimensionprinting includes joining material together to make thethree-dimensional object. The three-dimensional printing processincludes, but is not limited to, fused filament fabrication, plasterbased three-dimensional printing, selective laser sintering, selectiveheat sintering, direct ink writing, and combinations thereof.

Another aspect of the present disclosure is a bone graft materialdelivery system. The system generally includes, but is not limited to:(1) an elongate tube including a distal end with at least one openingconfigured to discharge bone graft material; and (2) a means foradvancing the bone graft material through the elongate tube. In oneembodiment, the means for advancing includes a manual force applied byan operator. Additionally, or alternatively, the means for advancing mayinclude a force applied by a motor.

In one embodiment, the means for advancing includes a plunger withnotches. Optionally, the means for advancing further includes a triggerconfigured to be actuated to the deliver bone graft material through theelongate tube. In one embodiment, the trigger comprises a ratchetingmechanism configured to engage the plunger notches to advance theplunger.

Additionally, or alternatively, the means for advancing may furtherinclude a gear to engage the plunger notches. In this manner, arotational motion of the gear is translated into linear movement of theplunger. Optionally, the motor is interconnected to the gear. In anotherembodiment, the system further comprises a knob to rotate the gear. Inthis manner, a user can advance bone graft material through the elongatetube by rotating the knob.

In one embodiment, the means for advancing includes a handle with atrigger configured to be actuated to cause movement of a plunger withinthe elongate tube. Optionally, the elongate tube is removably coupled tothe handle.

In one embodiment, the system further comprises at least two vent portsformed in the elongate tube. The vent ports are configured to releaseair from the elongate tube. In one embodiment, the at least one openingcomprises at least two lateral openings configured to discharge bonegraft material.

The elongate tube may be generally linear. In another embodiment, theelongate tube is flexible. The system may optionally include one or moreof an endoscope and a camera associated with the elongate tube.

Still another aspect of the present disclosure is method for deliveringbone graft material to a surgical location, such as a disc space. Themethod includes one or more of, but is not limited to: (1) providing abone graft delivery device comprising a hollow tube with a longitudinalaxis, a proximal end and a distal end, and at least one distal opening,the hollow tube adapted to receive bone graft material; (2) loading bonegraft material into the hollow tube; (3) inserting a plunger into thehollow tube, the plunger having a distal end with an exterior surfacecontoured to form a substantially congruent fit with a hollow interiorof the hollow tube, wherein the hollow tube and the plunger areconfigured to deliver the bone graft material through the at least onedistal opening; (4) advancing the bone graft material through the hollowtube with a means for advancing; and (5) discharging the bone graftmaterial from the at least one distal opening of the hollow tube,wherein the bone graft material discharged from the at least one distalopening is sufficient to substantially fill a disc space with the bonegraft material.

In one embodiment, the distal end of the hollow tube is at leastpartially closed. Additionally, or alternatively, the distal end of thehollow tube may be at least partially open. Optionally, the hollowinterior of the hollow tube has a generally rectangular cross-section.In one embodiment, the hollow tube is generally linear. Additionally, oralternatively, the hollow tube may be flexible. In another embodiment,the distal end of the hollow tube comprises a bullet shaped distal tip.In still another embodiment, the at least one distal opening comprisestwo openings on lateral sides of the hollow tube.

Optionally, the plunger includes teeth or notches. The teeth may beformed along a longitudinal axis of the plunger. In one embodiment, themeans for advancing engages the teeth of the plunger to advance the bonegraft material. Additionally, or alternatively, the means for advancingmay include a ratcheting mechanism that is actuated to advance theplunger through the hollow tube. In another embodiment, the plunger ispneumatically actuated to advance the bone graft material.

In one embodiment, the means for advancing further comprises a trigger.The trigger is configured to engages the plunger to advance the plungerthrough the hollow tube. In one embodiment, the trigger is pivotallymounted. Optionally, the trigger may be associated with a handle of thebone grade delivery device.

In one embodiment, the means for advancing includes a gear. The gearincludes teeth that engage the plunger to advance the bone graftmaterial. Optionally, the gear teeth engage the teeth of the plunger.

Additionally, or alternatively, the means for advancing includes amotor. The motor is configured to engage the plunger to advance the bonegraft material. In one embodiment, the motor is interconnected to thegear.

In one embodiment, the at least one distal opening is formed through alateral surface of the hollow tube. Optionally, in one embodiment, thehollow tube is configured to facilitate attachment of a funnel. Thefunnel may serve as a reservoir for application of bone graft materialwhich can then be pushed into the hollow tube and discharged into thedisc space. Accordingly, the method may further comprise interconnectinga funnel to the hollow tube.

The method may further include venting air from the hollow tube throughat least one vent port positioned between the proximal end and thedistal end of the hollow tube as the bone graft material is advancedthrough the hollow tube.

In one embodiment, the method further includes interconnecting thehollow tube to a handle of the bone graft delivery device, the handleincluding the means for advancing.

Optionally the method further includes coupling a detachable implant tothe distal end of the hollow tube. The implant is adapted to receivebone graft material from the hollow tube. The method may also includeexpanding the implant in the surgical location. Expanding the implantmay comprise rotating a portion of the implant. In one embodiment, theimplant is expanded in the surgical location prior to the step ofloading bone graft material into the hollow tube.

The step of loading bone graft material may comprise providing a volumeof the bone graft material that is at least approximately two timesgreater than a volume of debrided disc material removed from the discspace. In one embodiment, the step of loading bone graft materialcomprises providing a volume amount of bone graft material 100% greaterthan conventionally employed for fusion procedures. In anotherembodiment, the step of loading bone graft material comprises providinga volume amount of bone graft material 200% greater than conventionallyemployed for fusion procedures. Additionally, or alternatively, the stepof loading bone graft material comprises providing a volume amount ofbone graft material 300% greater than conventionally employed for fusionprocedures. In still another embodiment, the step of loading bone graftmaterial comprises providing a volume amount of bone graft material 400%greater than conventionally employed for fusion procedures.

Optionally, a volume of the bone graft material discharged from the atleast one distal opening is at least approximately two times greaterthan a volume of debrided disc material removed from the disc space.

One aspect of the present disclosure is to provide a bone graft materialdelivery system. The bone graft material delivery system generallyincludes, but is not limited to, one or more of: (1) a hollow tube toreceive bone graft material, the hollow tube having: (a) a proximal end;(b) a distal end with at least two lateral openings; (c) a hollowinterior from the proximal end to the distal end; and (d) at least onevent port; and (2) a plunger adapted for inserting into the proximal endof the hollow tube, the plunger having a distal end with an exteriorsurface contoured to form a substantially congruent fit with the hollowinterior of the hollow tube, wherein the hollow tube and the plunger areconfigured to deliver bone graft material through the at least twolateral openings in the distal end.

Optionally, the at least one vent port is oriented transverse to anextended axis of the hollow tube. In another embodiment, the at leastone vent port is configured to release air from the hollow interior ofthe hollow tube. Additionally, the at least one vent port can have atleast one of a size and a shape to prevent passage of the bone graftmaterial through the at least one vent port. In another embodiment, theat least one vent port comprises a proximal vent port, a medial ventport, and a distal vent port. Additionally, or alternatively, the atleast one vent port has a shape that is generally circular or generallylinear. In one embodiment, the at least one vent port has a width ofless than approximately 2 mm.

In one embodiment, the hollow tube comprises a first portioninterconnected to a second portion. Optionally, the first portion issonically welded to the second portion along a joint.

Additionally, the system may further comprise a grip interconnectable tothe proximal end of the hollow tube, the grip operable to advance theplunger into the hollow interior of the hollow tube. In one embodiment,the grip includes a trigger operable to incrementally advance theplunger toward the distal end of the hollow tube.

In one embodiment, the distal end of the hollow tube comprises a closeddistal tip. Optionally, the hollow interior of the hollow tube has agenerally rectangular interior cross-section. Additionally, the hollowtube may be generally linear. In one embodiment, the distal end isoriented transverse to the proximal end. In another embodiment, thehollow tube is flexible. Accordingly, in one embodiment, the plunger isflexible.

In one embodiment, at least a portion of the hollow tube is generallytransparent or translucent such that the plunger is at least partiallyvisible within the hollow tube. In another embodiment, the systemfurther comprises one or more of an endoscope and a camera associatedwith the distal end of the hollow tube.

Another aspect of the present disclosure is a bone graft materialdelivery system. The system generally comprises: (1) an elongate tubeincluding a distal end with at least one opening configured to dischargebone graft material; and (2) a handle at a proximal end of the elongatetube configured to be actuated to deliver bone graft material throughthe elongate tube, the handle comprising a ratcheting mechanismconfigured to advance a plunger to push bone graft material through theelongate tube. In one embodiment, at least one opening comprises atleast two lateral openings configured to discharge bone graft material.Optionally, the handle comprises a trigger configured to be actuated tocause movement of the plunger within the elongate tube. Additionally, oralternatively, the system may further comprise at least two vent portsformed in the elongate tube configured to release air from the elongatetube.

In one embodiment, the elongate tube is removably coupled to the handle.In another embodiment, the elongate tube is generally linear.Optionally, the distal end of the elongate tube is oriented transverseto the proximal end. In another embodiment, the elongate tube isflexible. Additionally, at least a portion of the elongate tube can begenerally transparent or translucent such that the plunger is at leastpartially visible within the elongate tube. In another embodiment, thesystem further comprises one or more of an endoscope and a cameraassociated with the distal end of the elongate tube.

Another aspect of the present disclosure is a method for delivering bonegraft material to a surgical location, comprising: (1) providing a bonegraft delivery device comprising a hollow tube with a lumen; (2) loadingbone graft material into the lumen of the hollow tube; (3) advancing thebone graft material through the lumen; and (4) discharging the bonegraft material from at least one opening at a distal end of the hollowtube. Optionally, a plunger is advanced through the lumen of the hollowtube to advance the bone graft material. In one embodiment, a ratchetingmechanism is actuated to advance the plunger through the lumen. Inanother embodiment, the plunger is pneumatically actuated to advance thebone graft material. Optionally, the bone graft material is advancedpneumatically through the lumen.

In one embodiment, advancing the bone graft material further comprisesactuating a trigger of a handle of the bone graft delivery device.Optionally, the at least one opening is formed through a lateral surfaceof the hollow tube. In one embodiment, the method further includesventing air from the hollow tube through at least one vent port as thebone graft material is advanced through the lumen.

In another embodiment, the method includes, after loading the bone graftmaterial into the lumen, interconnecting the hollow tube to a handle ofthe bone graft delivery device, the handle configured to advance theplunger through the lumen. The method may optionally include one or moreof detaching an implant from the distal end of the hollow tube and,after detaching the implant, removing the hollow tube from the surgicallocation. Optionally, the method includes expanding the implant in thesurgical location. In one embodiment, expanding the implant comprisesrotating a portion of the implant such that a first plate of the implantmoves away from a second plate of the implant. Additionally, the portionof the implant rotates without moving transversely with respect toeither the first or the second plate.

According to various embodiments of the present disclosure, one aspectof the invention is to provide an integrated fusion cage and graftdelivery device that comprises a tubular member, which is substantiallyhollow or contains at least one inner lumen and that has a generallyrectangular cross-sectional shape. This generally rectangularcross-sectional shape offers a larger amount of surface area throughwhich bone graft material may be inserted and ejected from the hollowtubular member. Furthermore, this generally rectangular shape is morecongruent with the size or shape of the annulotomy of most disc spaces,which frequently are accessed by a bone graft delivery device fordelivery of bone graft. However, as one skilled in the art wouldappreciate, the tool cross-section need not be limited to a generallyrectangular shape. For example, cross-sections of an oval shape or thosewith at least one defined angle to include obtuse, acute, and rightangles can provide a shape in some situations that is more congruentwith the size or shape of the annulotomy of a particular disc space. Asubstantially round shape may also be employed that provides the surgeonwith an indication of directional orientation.

The phrase “removably attached” and/or “detachable” is used herein toindicate an attachment of any sort that is readily releasable.

The phrase “integrated fusion cage”, “spinal fusion implant”,“biological implant” and/or “fusion cage” is used here to indicate abiological implant.

According to various embodiments of the present disclosure, it isanother aspect that the hollow tubular member further comprise at leastone opening on a lateral face or surface of the hollow tubular member,at one distal end, for ejecting bone graft material into a bone graftreceiving area, such as a disc space, such that the bone graft materialis ejected from the hollow tubular member through an additional implant,such as a structural cage implant. In addition, the graft material isdispersed into the area of the debrided disc space surrounding andwithin the cage. Furthermore, the structural cage implant is removablyattached to the hollow tubular member so as to be deposited into thesurgical area. Thus, the device may be used in an integrated andnear-simultaneous method for depositing bone graft material into adebrided disc space through a structural cage implant and leaving thestructural implant.

According to various embodiments of the present disclosure, one aspectof the invention is to provide an integrated fusion cage detachablecomponent of the integrated fusion cage and graft delivery device thatcomprises a biological implant that fits over the distal end of thesubstantial hollow tube, and which has a shape that is substantiallycongruent with the distal end of the hollow tube. However, the shape andconfiguration of the integrated fusion cage need not be limited to agenerally rectangular shape. For example, cross-sections of an ovalshape or those with at least one defined angle to include obtuse, acute,and right angles can provide a shape in some situations that is morecongruent with the size or shape of the annulotomy of a particular discspace. A substantially round shape may also be employed that providesthe surgeon with an indication of directional orientation.

In a preferred embodiment, the fusion cage has a tapered tip, andseveral open channels along the medial surfaces. In a preferredembodiment, the fusion cage and/or the bone graft delivery portion ofthe integrated fusion cage and graft delivery device is of oblong orrectangular, or square shape. The integrated fusion cage and graftdelivery device is designed to avoid blocking or impacting bone graftmaterial into a surgical disc space, thereby limiting the bone graftmaterial that may be delivered, and not allowing available fusion spaceto be fully exploited for fusion.

In a preferred embodiment, the fusion cage has a keel-shaped tip toseparate disk and prevent annular penetration. Also, the fusion cage hasdual portals for bone graft discharge. In one embodiment, the medialopenings are larger than the lateral openings. In another embodiment,the medial openings and the lateral openings are of the same size. Inanother embodiment, the medial and the lateral openings are symmetrical.In another embodiment, the medial openings are smaller than the lateralopenings.

Further, the fusion cage may be designed in variable heights and lengthsso that it fits snugly into the prepared disk space.

In a preferred embodiment that is ideal for anterior lumbar interbodyfusion, the fusion cage has two portals for bone graft dischargepositioned on opposite sides of the fusion cage.

In a preferred embodiment that is ideal for direct lateral interbodyfusion, the fusion cage has six portals for bone graft discharge, withthree portals on one side of the fusion cage and three portals on anopposite side of the fusion cage. And, in a preferred embodiment that isideal for post-vertebrectomy use, two opposing wall portions of thefusion cage are substantially porous to bone graft slurry, while thesubstantial remainder of the wall of the fusion cage is substantiallyimpervious to bone graft slurry.

In another embodiment of the device, the hollow tube engages with thefusion cage via a break-off collar and the plunger inserts into theinterior of the hollow tube. The break-off collar may be severed by anyof several means, to include application of torsion and/or rotationalforce and/or lateral force to the break-off collar, for example bytwisting on the hollow tube and/or the plunger. The break-off collar maybe formed by any of several means, comprising a thinner and/or reducedcross-sectional, that is thickness, a pre-set fracture-line, one or morenotches, a frangible portion defined by a discrete, extended area thatis weaker in one or more respects as compared to surrounding and/oradjacent material, and any means known to those skilled in the art toachieve reliable break-off. Preferably a clean break is achieved suchthat no surgically significant issues arise by such severance of thecage-portion and the hollow for the portion. In other embodiments, otherways devices and features can be employed to achieve separation of afirst delivery tube structure and a second structure intended to remainin a patient. For example, electric and/or magnetic disconnectingmechanisms can be used in lieu of a physical breaking/severing of twodiscrete portions that define the above-referenced first and secondstructures. A smooth edge preferably remains after such severance of thecage. Moreover, it will be understood as being within the scope of thepresent invention to use more conventional coupling/decouplingmechanisms to achieve desired separation of the first and secondstructures, e.g. bayonet mounted features, tongue and groove,male/female interlocking structures, clamping devices, nestedarrangements, etc., all of which find support in the various citedreferences incorporated herein by reference. In one example method ofuse, the connected hollow tube and fusion cage is inserted into thesurgical area, bone graft material is inserted into the hollow tube (oralready provided as a pre-packaged material), the plunger is pushed intothe hollow tube, so as to deliver bone graft material to the site, thenthe plunger is reversed or pulled-out so to retreat from the site andmove higher or beyond the break-off collar, and then the break-offcollar is broken so as to disengage the fusion cage from the hollow tubeand therein leave the fusion cage at the surgical site. In anotherembodiment of the device, the hollow tube engages with a connectorconduit which in turn connects with the fusion cage via a break-offcollar. One or more connectors connect the hollow tube with theconnector conduit. The hollow tube fits over the connector conduit. Theone or more connectors fit through the hollow tube and the connectorconduit. Alternately, the hollow tube may fit over the connector conduitvia a press-fit, aka interference fit, without need of one or moreconnectors. In one embodiment, the connectors comprise set screws, pinsand tabs. The connector conduit allows, for example, various fusioncages designs to be fitted to a common hollow tube/plunger combination.This allows, for example, the common hollow tube/plunger combination tobe re-sterilized and thus reused in multiple surgical procedures. In oneembodiment, the hollow tube/plunger combination is reusable, and thefusion cage is disposable.

In one embodiment of the connector conduit, the connector conduit is ofcircular cross-section. In another embodiment, the connector conduit isof conical shape, or any shape that allows a transition in diameterbetween the fusion cage and the hollow tube.

In one example method of use, the hollow tube is inserted over theconnection conduit (which is attached to the fusion cage), then insertedinto the surgical area, bone graft material is inserted into the hollowtube (or already provided as a pre-packaged material), the plunger ispushed into the hollow tube (and past the connection conduit), so as todeliver bone graft material to the site, then the plunger is reversed orpulled-out so to retreat from the site and move higher or beyond thebreak-off collar, and then the break-off collar is broken so as todisengage the fusion cage from the hollow tube (which is still connectedto the connection conduit) and therein leave the fusion cage at thesurgical site.

The break-off collar may be severed by any of several means, to includeapplication of torsion and/or rotational force and/or lateral force tobreak-off collar, for example by twisting on the hollow tube and/or theplunger.

In one embodiment of the fusion cage, the fusion cage is of rectangularcross-section, such that one pair of opposite sides, for example aheight first pair of sides, has a dimension of approximately 8-14 mm,and a second pair of opposite sides, for example a length dimension, ofapproximately 22-36 mm. One skilled in the art will appreciate that theexact dimensions of the fusion cage may be adapted to conform toparticulars of the surgical site, for example, the relative sizingbetween the particular vertebrae in which bone graft material and/or afusion cage is to be inserted. In other embodiments of the fusion cage,the fusion cage is of a substantially cylindrical shape. For example, apreferred embodiment of a fusion cage for use in an ALIF procedure formsa substantially cylindrical shape, with a height of approximately 8-14mm and a diameter of less than about 36 millimeters. As another example,a preferred embodiment of a fusion cage for use in conjunction with avertebrectomy has a substantially cylindrical shape with a height equalto or greater than the height of the vertebra (or the collective heightof the vertebrae) it is intended to replace and a diameter of less thanabout 36 millimeters. Preferably, the separation “zone” between the cageand the hollow filling tube is at one end of the cage, preferably theend of the cage (when implanted) closer to the incision site.

A preferred method of using the integrated fusion cage and graftdelivery device comprises precisely inserting the integrated fusion cageand graft delivery device, in one or more of the embodiments containedherein, into the surgical area. The integrated fusion cage and graftdelivery device is then filled with bone graft material in its one ormore substantially hollow tubes, the one or more plungers are insertedinto the one or more hollow tubes, and the one or more plunger arepushed into the one or more hollow tubes, guided precisely as enabled bythe minimal profile of the device, therein controllably depositing thebone graft material into the surgical area through and into the surgicalimplant cage. The surgical implant device may then be selectablydetached from the integrated fusion cage and graft delivery device so asto remain at the surgical site.

Another method of using the integrated fusion cage and graft deliverydevice comprises inserting the integrated fusion cage and graft deliverydevice into a prepared disk space, such that the fusion cage portionfits snugly into the prepared disk space (the fusion cage is designed invariable heights and lengths so as to fit snugly into the prepared diskspace), pushing the plunger through the hollow shaft so as to pushbiological fusion material (e.g. bone graft) through the hollow shaft toflow the biological material through the fusion cage's open lateraland/or medial portals in communication with the hollow tube and plunger,thereby delivering biological material into the prepared disk space,after which the fusion cage is detached from the hollow tube and left inthe disk space. Thus, the fusion cage is left in the disk space with amaximum and/or optimal amount of biological material near-simultaneouslydelivered within the fusion cage and/or surrounding the fusion cage inthe disk space.

Using the integrated fusion cage and graft delivery device as describedovercomes a problem associated with the traditional separate applicationof bone graft material and insertion of a fusion cage. Specifically, inthe traditional method, the volume of disk space which does not containbone graft material is limited, which, for example, limits theeffectiveness of the surgical procedure. For example, using thetraditional two-step procedure, bone graft may be inserted into, forexample, a cylindrically shaped area of radius r to a height h of 8 mm,and then a cylindrically shaped fusion cage inserted of height h of 14mm. Thus, the surgical area is left without a complete volume of bonegraft material, i.e. because the volume of a cylinder is Volume=πr2h,the bone graft area is left without πr2(14 mm-8 mm), or 6πr2 of bonegraft material. (Note that this represents a 75% increase in bone graftmaterial delivered to the surgical site for these example dimensions).This effectively dilutes the bone graft material and reduces itseffectiveness. The present invention can substantially or completelyfill the available disk space with bone graft material becausedistraction of the disk space is performed substantially simultaneouslywith application of the fusion cage. Because more biological material isdelivered to the prepared disk space, the fusion rate should increase.Also, by directly implanting fusion material, e.g. bone graft material,though a fusion cage positioned for detachment (and then detached) as asingle step, time is saved and there is less manipulation of thesensitive nerve tissue at the fusion site (which increases safety).

Furthermore, the integrated fusion cage and graft delivery device may beused without the surgical implant delivery device portion such that themethod comprises precisely inserting the integrated fusion cage andgraft delivery device, in one or more of the embodiments containedherein, into the surgical area that may already contain one or moreadditional implants, such as a structural cage implant. The integratedfusion cage and graft delivery device is then filled with bone graftmaterial in its one or more substantially hollow tubes, the one or moreplungers are inserted into the one or more hollow tubes, and the one ormore plunger are pushed into the one or more hollow tubes, guidedprecisely as enabled by the minimal profile of the device, thereincontrollably depositing the bone graft material into the surgical areawithout depositing bone graft material into the path of any structuralcage implant or other implant that may already be present.

According to a still further aspect of the present invention, theintegrated fusion cage may be introduced into a spinal target sitewithout the use of the graft delivery device. That is, the integratedfusion cage may be introduced into a spinal target site through use ofany of a variety of suitable surgical instruments having the capabilityto engage the implant. The integrated fusion cage is capable of beingused in minimally invasive surgical procedures, needing only arelatively small operative corridor for insertion. The integrated fusioncage may also be used in open procedures. According to a still furtheraspect of the present invention, the integrated fusion cage of thepresent invention may be used in a variety of configurations in a fusionprocedure, including but not limited to (and by way of example only)unilateral, paired unilateral and bilateral.

Furthermore, the integrated fusion cage and graft delivery device andmethod of use is applicable to position and deliver fusion cages fromthe side, directly anterior or in the anterior fusion cages of thecervical spine.

In a preferred embodiment, the integrated fusion cage and graft deliverydevice comprises a hollow tube or contains at least one inner lumenconstructed to receive bone graft, and a plunger adapted for insertionat least partially within the hollow tube and preferably through thefull extent of the hollow tube. The plunger of some embodiments isgenerally of the same geometric configuration as the hollow interiorpotion of the hollow tube so that the plunger, once fully inserted in tothe hollow tube, is substantially congruent with the hollow interiorportion of the hollow tube, e.g. both the plunger and the hollow tubeare substantially the same shape and/or class. The plunger preferablyextends about the same length as the hollow tube, and further comprisesan end portion, e.g. at least one knob or handle for grasping andmanipulation by a user, or in robotic or automated or semi-automatedcontrol or surgeries, by a machine.

Also, according to a preferred embodiment, the hollow interior portionof the hollow tube further comprises a sloped or curved surface at asecond end (e.g. positioned near a place for deposit of bone graftmaterial) adjacent and opposite a lateral window or opening in a lateralface of the hollow tube. As the interior of the hollow tube comprises asloped or curved surface at its second end, the plunger also comprises asloped or curved surface at a second end of the plunger. The plungerterminates opposite the curved surface at its second end with alaterally faced surface, which corresponds to the lateral window oropening at the second end of the hollow tube. The distal end of thehollow tube is fitted with a substantially conformal fusion cage thatcovers the exterior surface of the hollow tube, fitted with one or moreopenings that align with one or more openings of the hollow tube. Thus,in cooperation, the plunger may be inserted into the opening of thehollow tube, and extended the entire length of the hollow tube, at leastto a point where the laterally faced surface of plunger is incommunication with the lateral window or opening at the second end ofthe hollow tube. This configuration permits a user to ejectsubstantially all of the bone graft material that is placed into thehollow tube in a lateral direction at the bone graft receiving area,through the substantially conformal and detachable fusion cage thatcovers the exterior surface of the hollow tube, optionally detach thedetachable fusion cage, during a surgical procedure.

In a preferred embodiment, the integrated fusion cage and graft deliverydevice comprises an integrated fusion cage that comprises a firstproximal end and a second distal end, wherein the first proximal endcontains an opening adapted to allow fitting and/or engagement to thedistal end of the hollow tube. This fitting and/or engagement may beover the external surface of the hollow tube or inside the interior ofthe hollow tube. Further, the integrated fusion cage may comprise one ormore medial openings and one or more lateral openings that align withone or more openings at the distal end of the hollow tube. Further, theintegrated fusion cage may contain surfaces, such as belts orstriations, along one or more medial surfaces of the integrated fusioncage. The integrated fusion cage is configured such that when a plunger,once fully inserted into the hollow tube, is substantially congruentwith the hollow interior portion of the hollow tube, e.g. both theplunger and the hollow tube are substantially the same shape and/orclass and bone graft material is delivered through the integrated fusioncage into the surgical area.

In one embodiment, a substantially hollow implant is detachablyinterconnected to a distal end of the hollow tube, the implant having aproximal end and a tapered distal end, the tapered distal end having anexterior tapered surface and a tapered interior surface, and the plungeradapted for inserting into the proximal end of the hollow tube, theplunger having a tapered distal end being contoured to the taperedinterior surface of the distal end of the implant to form a conformingfit between the tapered distal end of the plunger and the taperedinterior surface of the distal end of the implant when the plunger isfully inserted into the implant such that bone graft material within thehollow tube is delivered to a graft receiving area through at least oneopening of the implant. Further, the distal end of the implant maycomprise a closed distal tip, and the tapered distal end of the plungermay be wedge-shaped and the tapered interior surface of the closeddistal tip of the distal end of the implant may be wedge-shaped.

The spinal fusion implant of the present invention may be used toprovide temporary or permanent fixation along an orthopedic target site.

The spinal fusion implant of the present invention may be provided withany number of additional features for promoting fusion, such as one ormore apertures extending between the top and bottom surfaces which allowa boney bridge to form through the spinal fusion implant.

The spinal fusion implant may also be provided with any number ofsuitable antimigration features to prevent the implant from migrating ormoving from the disc space after implantation. Suitable anti-migrationfeatures may include, but are not necessarily limited to, angled teethor ridges formed along the top and bottom surfaces of the implant and/orrod elements disposed within the distal and/or proximal ends.

According to a further aspect of the present invention, the spinalfusion implant may be provided with one or more radiographic markers atthe proximal and/or distal ends. These markers allow for a more detailedvisualization of the implant after insertion (through radiography) andallow for a more accurate and effective placement of the implant.

According to a still further aspect of the present invention, the distalend of the spinal fusion implant may have a conical (bullet-shaped)shape including a pair of first tapered (angled) surfaces and a pair ofsecond tapered (angled) surfaces. The first tapered surfaces extendbetween the lateral surfaces and the distal end of the implant, andfunction to distract the vertebrae adjacent to the target intervertebralspace during insertion of the spinal fusion implant. The second taperedsurfaces extend between the top and bottom surfaces and the distal endof the spinal fusion implant, and function to maximize contact with theanterior portion of the cortical ring of each adjacent vertebral body.Furthermore, the second tapered surfaces provide for a better fit withthe contour of the vertebral body endplates, allowing for a moreanterior positioning of the spinal fusion implant and thus advantageousutilization of the cortical rings of the vertebral bodies.

Another embodiment for the integrated fusion cage and graft deliverydevice comprises a detachable fusion cage that is detachable, orremovably attached, by any of several means. As disclosed above, in oneembodiment, the fusion cage is substantially conformal with the distalend of the hollow tube in that it covers the exterior surface of thehollow tube, wherein the fusion cage is configured with one or moreopenings that align with one or more openings of the hollow tube. In onepreferred embodiment, the fusion cage of the integrated fusion cage andgraft delivery device forms an interference fit with the fusion cage,such that when the integrated fusion cage and graft delivery device isinserted into the surgical area, the integrated fusion cage and graftdelivery device presses against bone and/or vertebrates such that whenan axial force is applied to the integrated fusion cage and graftdelivery device in a rearward direction (toward the proximal end of theintegrated fusion cage and graft delivery device), the fusion cagedetaches from the integrated fusion cage and graft delivery device andthereby remains in the surgical area.

In another embodiment for the integrated fusion cage and graft deliverydevice and its method of use, the fusion cage is substantially filledwith bone graft material after the fusion cage is implanted. In anotherembodiment for the integrated fusion cage and graft delivery device andits method of use, the fusion cage is substantially filled with bonegraft material simultaneously with the implantation of the fusion cage.

In another embodiment for the integrated fusion cage and graft deliverydevice and its method of use, the fusion cage and/or the bone graftmaterial associated with the fusion cage may be accessed duringsubsequent surgical operations.

In another embodiment for the integrated fusion cage and graft deliverydevice and its method of use, the fusion cage is a separate device, forexample a pre-packaged implant device, which may be installedindependently from the integrated fusion cage and graft delivery deviceor installed in coordination with the integrated fusion cage and graftdelivery device. In either situation, the device may be used to providebone graft material in and/or around the prepackaged implant.

In another embodiment for the integrated fusion cage and graft deliverydevice and its method of use, some or all of the bone graft material isprovided as a component of a pre-packaged implant. In another embodimentfor the integrated fusion cage and graft delivery device, the detachablefusion cage is detachable by way of an indent-tab that penetrates theinterior of the hollow tube, such, when the plunger is substantiallyinserted into the hollow tube, the indent-tab is pushed out from theinterior of the hollow tube so as to no longer be attached to theintegrated fusion cage and graft delivery device, thereby remaining inthe surgical area.

In another embodiment, the hollow tube is of cylindrical shape andincludes one or more locking tabs or indent tabs configured to engageone or more locking slots of the fusion cage. The locking tabs maypermanently or not permanently engage the locking slots, and may be of ashape to include rectangular, circular and oblong. In one embodiment ofthe locking tabs and locking slots, the locking tabs and locking slotsengage one another by rotating the hollow tube clockwise and arereleased by counterclockwise rotation. In another embodiment of theconfiguration of the locking tabs and locking slots, the locking tabsand locking slots engage one another by rotating the hollow tubecounterclockwise and are released by clockwise rotation.

In another embodiment, the fusion cage has internal ramps which assistin directing the bone graft material to one or more openings in thefusion cage.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by way of receipt of anelectrical, mechanical, pneumatic, hydraulic or other communicationimparted by the user upon the plunger and/or hollow tube so as to detachthe fusion cage and thereby deposit the fusion cage into the surgicalarea.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by way of a Luer taperor Luer fitting connection, such as in a Luer-Lok® or Luer-Slip®configuration or any other Luer taper or Luer fitting connectionconfiguration. For purposes of illustration, and without wishing to beheld to any one embodiment, the following U.S. Patent Application isincorporated herein by reference in order to provide an illustrative andenabling disclosure and general description of means to selectablydetach the fusion cage of the integrated fusion cage and graft deliverydevice: U.S. Patent Appl. No. 2009/0124980 to Chen.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by way of a pedicledart by threadable rotation to achieve attachment, detachment, and axialmovement. Other ways include a quick key insertion, an external snapdetent, or magnetic attraction or any other structure. For purposes ofillustration, and without wishing to be held to any one embodiment, thefollowing U.S. Patent Application is incorporated herein by reference inorder to provide an illustrative and enabling disclosure and generaldescription of means to selectably detach the fusion cage of theintegrated fusion cage and graft delivery device: U.S. Patent Appl. No.2009/0187194 to Hamada.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by use of magnetism.More specifically, the detachable fusion cage can be made to feature amagnetic field pattern and a resulting force R that are adjustable andmay be of different character than the rest of the integrated fusioncage and graft delivery device. With permanent magnets, such adjustmentscan be made mechanically by orienting various permanent magnet polargeometries and corresponding shapes relative to one another. U.S. Pat.No. 5,595,563 to Moisdon describes further background regarding suchadjustment techniques, which is hereby incorporated by reference in itsentirety. Alternatively, or additionally, electromagnets could be usedin combination with permanent magnets to provide adjustability. Infurther embodiments, the magnets and corresponding fields and theresultant magnetic field pattern can include both attraction forces fromplacement of opposite pole types in proximity to one another andrepulsion forces from placement of like pole types in proximity to oneanother. As used herein, “repulsive magnetic force” or “repulsive force”refers to a force resulting from the placement of like magnetic poles inproximity to one another either with or without attractive forces alsobeing present due to opposite magnetic poles being placed in proximityto one another, and further refers to any one of such forces whenmultiple instances are present. U.S. Pat. No. 6,387,096 is cited as asource of additional information concerning repulsive forces that areprovided together with attractive magnetic forces, which is herebyincorporated by reference. In another alternative embodiment example,one or more of surfaces of the fusion cage are roughened or otherwiseinclude bone-engaging structures to secure purchase with vertebralsurfaces. In yet other embodiments, the selectable detachable featurebetween the detachable fusion cage and the integrated fusion cage andgraft delivery device can include one or more tethers, cables, braids,wires, cords, bands, filaments, fibers, and/or sheets; a nonfabric tubecomprised of an organic polymer, metal, and/or composite; an accordionor bellows tube type that may or may not include a fabric, filamentous,fibrous, and/or woven structure; a combination of these, or suchdifferent arrangement as would occur to one skilled in the art.Alternatively or additionally, the selectable detachable feature betweenthe detachable fusion cage and the integrated fusion cage and graftdelivery device can be arranged to present one or more openings betweenmembers or portions, where such openings extend between end portions ofthe fusion cage. For purposes of illustration, and without wishing to beheld to any one embodiment, the following U.S. Patent Application isincorporated herein by reference in order to provide an illustrative andenabling disclosure and general description of means to selectablydetach the fusion cage of the integrated fusion cage and graft deliverydevice: U.S. Patent Appl. No. 2011/0015748 to Molz et al.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by use of plasmatreatment. The term “plasma” in this context is an ionized gascontaining excited species such as ions, radicals, electrons andphotons. (Lunk and Schmid, Contrib. Plasma Phys., 28: 275 (1998)). Theterm “plasma treatment” refers to a protocol in which a surface ismodified using a plasma generated from process gases including, but notlimited to, O2, He, N2, Ar and N2 O. To excite the plasma, energy isapplied to the system through electrodes. This power may be alternatingcurrent (AC), direct current (DC), radiofrequency (RF), or microwavefrequency (MW). The plasma may be generated in a vacuum or atatmospheric pressure. The plasma can also be used to deposit polymeric,ceramic or metallic thin films onto surfaces (Ratner, Ultrathin Films(by Plasma deposition), 11 Polymeric Materials Encyclopedia 8444-8451,(1996)). Plasma treatment is an effective method to uniformly alter thesurface properties of substrates having different or unique size, shapeand geometry including but not limited to bone and bone compositematerials. Plasma Treatment may be employed to effect magneticproperties on elements of the integrated fusion cage and graft deliverydevice, or to provide selectable detachment of the fusion cage. Forpurposes of illustration, and without wishing to be held to any oneembodiment, the following U.S. Patent Application is incorporated hereinby reference in order to provide an illustrative and enabling disclosureand general description of means to selectably detach the fusion cage ofthe integrated fusion cage and graft delivery device: U.S. Pat. No.7,749,555 to Zanella et al.

One having skill in the art will appreciate that the fusion cage may beselectably detachable to the integrated fusion cage and graft deliverydevice, for example, by means that 30 mechanically grasp the head, meansthat attach by vacuum, and means that attach by friction, or other meansknown to those of skill in the art for attaching the head of anapparatus to the shaft of an apparatus.

It is another aspect of the present disclosure that the distal end ofthe integrated fusion cage and graft delivery device be equipped withvarious other tools to aid in the procedure. Such tools may include, forexample, devices used to assess the condition of the implantation siteand surrounding tissue. This may include, for example, a device thattransmits or provides an image or signal which carries an image forvisual inspection and photography. Such an image capture device mayinclude, for example, a device to illuminate the implant site coupledwith an image capture and/or transmission device. Another tool may alsoinclude, for example, a device that aids in irrigation or drainage ofthe surgical site, a tool used to sample or biopsy tissue.

Another embodiment for the integrated fusion cage and graft deliverydevice comprises a hollow tube constructed to receive bone graft, wherethe hollow tube has a proximal and distal end, a plunger adapted forinsertion at least partially within the hollow tube at the proximal endof the hollow tube, whereby the plunger is constructed and arranged withrespect to the hollow tube so as to prevent rotation of the plungerduring insertion into the hollow tube, whereby the plunger has a distalend that is contoured to an interior surface of the distal end of thehollow tube such that the contoured distal end of the plunger is nearlycongruent with the interior surface of the distal end of the hollow tubefor removing substantially all of the bone graft received by the hollowtube and whereby the bone graft is delivered to the graft receivingarea. Still another embodiment provides a rifling structure in thehollow tube interior that facilitates rotational movement of the plunderalong a lengthwise axis of the hollow tube, therein delivering asubstantially steady pressure and/or rate of delivery of the bone graftmaterial as the plunger descends the hollow tube when the plunger isforced through the hollow tube. The rifling or screw-like movement mayalso translate to a predetermined delivery of material per fullrotation, e.g. each 360-degree rotation of the plunger equates to 5 ccof bone graft material delivered to the bone graft site.

Another aspect of the present invention includes providing a hollow tubeand plunger assembly, in which the hollow tube and/or the plungerassembly are disposable. The tube may also be at least portions ofbiocompatible material which can stay in the canal without impairing thefinal implantation. Alternatively, it may thus be a material that isresorbable, such as a resorbable polymer, in the canal afterimplantation, so as not to interfere with the growth of the bone orstability of the implant.

A further embodiment of the invention provides pre-packaged inserts forloading into the hollow tube element, or if there are a plurality ofhollow tube elements, into one or more of the hollow tube elements. Thepre-packaged inserts may be of varying lengths, and/or layered ofdiffering materials or components, to include the patient's own bonegraft matter.

Another embodiment of the present invention provides an integratedfusion cage and graft delivery system, by which a hollow tube and/or ahollow tube/plunger assembly can be prepared prior to opening a patient,thus minimizing the overall impact of the grafting aspect of a surgicalimplantation or other procedure. Moreover, the hollow tube may be madeto be stored with bone graft in it for a period of time, whether thetube is made of plastic, metal or any other material. Depending upon thesurgical application, it may be desirable to only partially fill thetube for storage, so that a plunger can be at least partially insertedat the time of a surgery.

A further embodiment of the present invention provides a bone graftinsertion apparatus comprising a hollow tube constructed to receive bonegraft, the hollow tube having a proximal and distal end whereby thehollow tube contains least one opening on a surface of the distal end ofthe hollow tube. The at least one opening is preferably positioned otherthan completely along the axial or longitudinal axis of the device. Thenumber and size and shape of such openings can vary but are preferablyadapted to deliver bone graft material in a direction substantiallytransverse to the axial extent of the substantially hollow tube. In oneembodiment, two or more apertures are provided. In certain embodiments,apertures are on the same side of the hollow tube, where in others,apertures are on different sides (e.g. opposing sides) of a hollow tube.A plunger, adapted for insertion at least partially within the hollowtube, is constructed and arranged with respect to the hollow tube so asto present at least one substantially flat contour, whereby the plungerhas a distal end that is contoured to an interior surface of the distalend of the hollow tube such that the contoured distal end of the plungeris nearly congruent with the interior surface of the distal end of thehollow tube. This facilitates removing substantially all of the bonegraft received by the hollow tube whereby the bone graft is delivered tothe graft receiving area. It is important to remove substantially all ofthe bone graft material as it is expensive and/or difficult to obtain.

In another embodiment of the present disclosure the distal end of theplunger is flexible to allow, for example, the user to maneuver thedistal end and thereby any bone graft material in the hollow tube to theimplantation site. One skilled in the art will appreciate that theflexible aspect of certain embodiments can be both passive and active innature. Active flexibility and manipulation in the distal end of theplunger may incorporate, for example, the manipulative capabilities ofan endoscope, including components for manipulation such as guidewiresalong the longitudinal axis of the shaft of the plunger.

In another embodiment of the invention, the distal end and the proximalend of the hollow tube are in communication via a conduit to enableelectrical, hydraulic, pneumatic, or mechanical transmission, the latersuch as a wire. Such hydraulic communication allows, for example, amedical or other liquid to be delivered or extracted from the surgicalarea. Such mechanical communication allows, for example, the distal endto be maneuvered precisely.

In another embodiment of the present disclosure, the hollow tube and/orplunger may be curved and/or may have an angular aspect, in addition tothe sloped or curved surface at a second end of the hollow tube/plunger.This shape may, for example, aid the surgeon in more comfortablyintroducing the delivery device to the implant site, be shaped to betteraccommodate implantation sites on right or left sides of the body, or beshaped to better accommodate right or left-handed surgeons. One havingskill in the art will appreciate that the delivery device may havemultiple angles and curved aspects which enable aspects of embodimentsof the present disclosure or aid in ergonomics.

In one embodiment of the present disclosure, the device furthercomprises a footing or shelf at the distal end of the tubular devicethat is nearest the operating site for preventing or mitigating risk ofinjury to the patient during surgery. According to this embodiment, thefooting may be flexible, semi-flexible, semi-rigid or rigid. The footingserves to protect the anatomy of the patient from being penetrated bythe hollow tube of the integrated fusion cage and graft delivery devicewhen the plunger is being inserted or during tamping of the hollow tubeor the plunger by the surgeon, which may occur during the surgicalprocedure for a variety of reasons. In certain embodiments, the distaltip region of the hollow tube comprises a softer, malleable and/or lessrigid material than the remainder of the hollow tube. For example, thedistal tip could be made of a bioactive collagen.

It is yet another aspect of the present disclosure to provide anintegrated fusion cage and graft delivery device that contains one ormore detachable elements for use in an operation where bone graftmaterial must be inserted into the integrated fusion cage and graftdelivery device and ejected to a bone graft receiving area. According tovarious embodiments, these detachable devices may include a detachablefunnel for gathering and inserting bone graft material at a graspableend of the integrated fusion cage and graft delivery device. The presentdisclosure may also comprise a plunger that has a detachable handle,which may be selectively removed to avoid blocking the surgeon's view ofthe operating site. The integrated fusion cage and graft delivery devicemay further comprise a detachable footing or shelf at one distal end ofthe hollow tubular member. In one embodiment this footing or shelf isselectively positionable about various points along the hollow tube. Forexample, a distal portion of the hollow tube has a rotatable portionthat can be positioned to deliver bone graft material to areas of a discspace in a manner such that a surgeon has angular directional control asto where bone graft material is directed. Other detachable elements arealso contemplated with the present invention, such as a funnel at theproximal end of the hollow tube, or exterior or interior guide wiresattached to the hollow tube, or a camera which is positioned near thedelivery site of the bone graft material.

In another embodiment of the invention, the device is configured suchthat the upper or first end of the device (that is, the end in which theplunger is inserted) is not substantially in-line with the second end ofthe device (that is, the end from which bone graft material is emittedand/or a fusion cage is attached). For example, the body of the hollowtube may be configured with an angle or kink along its length, appearingto be rotated along its length. In this embodiment, the plunger elementis flexible and/or conformable so as to flex inside of the tube portionand otherwise traverse through the tube portion. This embodiment of thedevice is useful, for example, when the user requires entry to the discspace at other than a right angle. Further, the angle or kink along thelength of the device may be configured is capable of selectively locking(e.g., by a pin) the upper device portion into a particular position,e.g. so that a desired angle is created between the upper device portionand the remaining portion of the device. The means for communicationitself can be locked to alternatively achieve this objective. In oneembodiment, when the rotating member is in an unlocked mode, the memberis free to rotate in at least one plane. The selective locking mechanismcan be remotely accessed by a user of the tool at the upper end of thehandle by, for example, an external shaft that communicates with thelocking mechanism of the rotating member on the distal end of the body.Yet another aspect of the present disclosure is that the device can bevariably angled to allow for a variety of insertion angles. A ratchetingadapter can be fitted to allow for this application.

The present invention can be used in veterinary conditions, in thethoracic spine or can be used for insertion of a laterally based diskreplacement.

Thus, according to various embodiments of the present disclosure, amethod of introducing bone graft material to a desired operating site(“bone graft receiving area”) is provided by use of a hollow tubularmember comprising a generally rectangular cross-sectional area, wherebythe desired operating area is capable of receiving at least one plunger.The one or more plunger having at least one distal end which is designedto accommodate ejecting bone graft or other material to be inserted intothe joint space or between intervertebral members in a generally lateraldirection, as opposed to a generally longitudinal direction (in relationto the direction of the primary axis of the device).

One skilled in the art will appreciate that the distal end of thetubular device need not be limited to those specific embodimentsdescribed above. Other forms, shapes or designs that enable theforegoing aspects of the present invention are hereby incorporated intothis disclosure. Forms, shapes and designs that relate to the provisionof an end of a tubular device to perform lateral introduction of bone orbone substitute to an operating site are considered to be within thescope of the present disclosure.

One aspect of the present invention provides an integrated fusion cageand graft delivery device system for delivering bone graft, in apartially formed, fully formed or unformed condition to a bone graftreceiving area in a body.

In yet another embodiment the hollow tube of the integrated fusion cageand graft delivery device may further comprise a funnel on the graspableend of the hollow tube, which may be selectively positioned about thegraspable end of the hollow tube, for facilitating insertion of new oradditional bone graft into the hollow tube. The funnel may take on avariety of shapes and sizes, depending on the nature of the bone graftmaterial being inserted in the hollow tube.

One embodiment of the substantially hollow tube provides that the hollowtube is telescoping, thereby allowing its length to be adapted to theparticular desires of the surgeon and/or the surgical area. In thisembodiment, the plunger may also be telescoping to substantially conformto the configuration and/or size and/or shape of the substantiallyhollow tube.

In another embodiment, the size and/or shape of the one or more hollowtubes of the device are sized to fit, and/or not substantially obscureaccess to the aperture of, the cannula or cannulas that the device isfitted through for delivery of bone graft material to the operatingsite. In this embodiment, the device's one or more pair of hollow tubesand plungers do not substantially impair access to the operating sitenor the surgeon's view of the operating site.

In one embodiment of the invention, a bone graft insertion apparatuscomprises:

a hollow tube constructed to receive bone graft, the hollow tube havingan extended axis and a proximal end and a distal end, the distal endhaving an interior surface; a plunger adapted for inserting into theproximal end of the hollow tube, the plunger having a distal end beingcontoured to the interior surface of the distal end of the hollow tubesuch that bone graft material within the hollow tube is delivered to agraft receiving area through at least one opening near the distal end ofthe hollow tube; wherein the graft receiving area is configured toaccommodate at least one substantially hollow implant.

In another embodiment of the invention, a bone graft insertion apparatuscomprises: a hollow tube constructed to receive bone graft, the hollowtube having a proximal and distal end; whereby the hollow tube containsleast one opening on a surface of the distal end of the hollow tube;whereby the opening on a surface of the distal end of the hollow tube ispositioned other than completely along the axial or longitudinal axis ofthe device; a plunger adapted for insertion at least partially withinthe hollow tube at proximal end of the hollow tube; whereby the plungeris constructed and arranged with respect to the hollow tube so as topresent at least one substantially flat contour; whereby the plunger hasa distal end that is contoured to an interior surface of the distal endof the hollow tube such that the contoured distal end of the plunger isnearly congruent with the interior surface of the distal end of thehollow tube for removing substantially all of the bone graft received bythe hollow tube; whereby the bone graft is delivered to a graftreceiving area.

In another embodiment of the invention, a method of inserting bone graftcomprises:

preparing a surgical area to receive bone graft; inserting a tool intothe surgical area, the tool consisting essentially of a hollow tubeadapted to receive bone graft, a plunger adapted for insertion into thehollow tube, the plunger constructed to prevent rotation duringinsertion into the hollow tube, the plunger having a distal endcontoured to the interior surface of the distal end of the hollow tube;providing bone graft material into the the hollow tube of the tool;inserting the plunger into the proximal end of the hollow tube;inserting the distal end of the hollow tube of the tool into surgicalarea; applying force to the plunger thereby advancing the plungerthrough the hollow tube wherein the bone graft is inserted into thesurgical area.

In another embodiment of the invention, an integrated fusion cage andgraft delivery device apparatus comprises: a hollow tube constructed toreceive bone graft, the hollow tube having an extended axis and aproximal end and a distal end, the distal end having an interiorsurface; a plunger adapted for inserting into the proximal end of thehollow tube, the plunger having a distal end being contoured to theinterior surface of the distal end of the hollow tube; a selectablydetachable fusion cage, the selectably detachable fusion cage having atleast one opening that substantially aligns with at least one openingnear the distal end of the hollow tube, such that bone graft materialwithin the hollow tube is delivered to a graft receiving area through atleast one opening of the selectably detachable fusion cage; and theselectably detachable fusion cage having a means for detachment wherebythe fusion cage is delivered to the graft receiving area.

In one embodiment, the device is not a caulking gun style device, thatis the bone graft material and/or the fusion cage are not deliveredand/or positioned using a hand-pump and/or hand-squeeze mechanism.Instead, the device delivers graft material and/or a fusion cage using ahollow tube and plunger arrangement which is not a caulking gun styledevice and further, does not appreciably disrupt or block the user'sview of the surgical site and/or enable precision delivery of bone graftmaterial and/or a fusion cage to the surgical site. Indeed, the deviceof one embodiment of the present disclosure is distinctly unlike thecaulking gun device of U.S. Pat. Appl. No. 2004/0215201 to Lieberman(“Lieberman”), which requires an L-shaped base member handle, rack teethto advance a plunger member, and user action on a lever of the L-shapedbase member handle to deploy bone graft material.

In one embodiment, the device of this application is not a caulking gunstyle device and does not comprise rack teeth, a base member handle andat least one component that obscures user viewing of the surgical site.Lieberman is incorporated by reference in its entirety for all purposes.

Similarly, in one embodiment, the device is distinctly unlike thecaulking gun device of U.S. Pat. Appl. No. 2002/0049448 to Sand et al(“Sand”), which requires a gun and trigger mechanism in which the usersqueezes together a gun-style handle to deploy material into bone. TheSand device obstructs the view of the user of the delivery site. In oneembodiment, the device of this application is not a caulking gun styledevice and does not comprise an opposing-levered, gun-style deliverymechanism and at least one component that obscures user viewing of thesurgical site. Sand is incorporated by reference in its entirety for allpurposes.

Other caulking gun type devices are described in U.S. Pat. Nos.8,932,295 and 9,655,748 which are each incorporated herein by referencein their entirety.

In one embodiment, the device is configured to deliver bone graftmaterial substantially laterally from its delivery end, that issubstantially not in the axial direction but rather substantially fromthe side and/or in a radial direction. This is distinctly different thandevices that deliver bone graft material along their vertical axis, thatis, along or out their bottom end, and/or obstruct the user view of thebone graft and/or fusion cage delivery site, such as that of U.S. Pat.Appl. No. 2010/0087828 to Krueger et al (“Krueger”), U.S. Pat. Appl. No.2009/0264892 to Beyar et al (“Beyar”), U.S. Pat. Appl. No. 2007/0185496to Beckman et al (“Beckman”), U.S. Pat. Appl. No. 2009/0275995 toTruckai et al (“Truckai”) and U.S. Pat. Appl. No. 2006/0264964 toScifert et al (“Scifert”). Krueger, Beyar, Beckman, Truckai and Scifertare incorporated by reference in their entireties for all purposes.

In one embodiment, the device is configured to deliver bone graftmaterial so as to completely fill the defined interior of its fusioncage and subsequently deliver bone graft material to the surroundingbone graft site, rather than, for example, to contain the bone materialas are the fusion cage designs of U.S. Pat. No. 7,846,210 to Perez-Cruet(“PerezCruet”). Further, the fusion device of this application featuresa distal tip that functions to precisely position the fusion device andstabilize the device during delivery of bone graft material. Perez-Cruetis incorporated by reference in its entirety for all purposes.

In one embodiment, a bone graft insertion apparatus is disclosed, thebone graft insertion apparatus comprising: a hollow tube constructed toreceive bone graft, the hollow tube having an extended axis and aproximal end and a distal end, the distal end having a substantiallytapered distal tip interior surface and a distal end interior surface ofrectangular cross-section; a plunger adapted for inserting into theproximal end of the hollow tube, the plunger having a distal endexterior surface of rectangular cross-section contoured to the distalend interior surface of the hollow tube, the plunger having asubstantially tapered distal tip contoured to the substantially tapereddistal tip interior surface of the hollow tube to form a substantiallycongruent fit, wherein bone graft material within the hollow tube isdelivered to a graft receiving area through one or more lateral openingsnear the distal end of the hollow tube, the one or more lateral openingssubstantially precluding the delivery of bone graft material directlyalong the axis of the hollow tube, the plunger precluded from rotatingwhen inserted into the hollow tube.

In another embodiment, a bone graft insertion apparatus is disclosed,the bone graft insertion apparatus comprising: a hollow tube having alength, a proximal end and a distal end, the hollow tube having arectangular cross-section, the distal end having a tapered tip interiorsurface and at least one opening; a plunger adapted for insertion withinthe hollow tube at the proximal end of the hollow tube, the plungerhaving a rectangular cross-section end portion and a distal tipcontoured to conform to the distal end of the hollow tube, the plungerhaving a length sufficient such that when fully inserted into the hollowtube, the plunger distal end contacts at least one opening.

In another embodiment, a bone graft insertion apparatus is disclosed,the bone graft insertion apparatus comprising: a hollow tube constructedto receive bone graft having an extended axis, a length, a proximal endand a distal end, the hollow tube having a rectangular cross-section,the distal end having a tapered tip interior surface with a terminus andtwo oval-shaped openings having an upper and a lower end located onopposite lateral sides of the distal end, the tapered tip extending intothe hollow tube and the terminus positioned adjacent to the oval-shapedopenings; a plunger adapted for insertion within the hollow tube at theproximal end of the hollow tube, the plunger having a rectangularcross-section end portion and a distal lower surface, the plunger havinga length sufficient such that when fully inserted into the hollow tube,the plunger distal lower surface contacts the hollow tube terminus at aposition adjacent to the oval-shaped openings, the plunger rectangularcross-section end portion forming a continuous surface adjacent each ofthe oval-shaped openings from a position opposite the terminus to apoint extending beyond the upper end of each oval-shaped opening;wherein bone graft material within the hollow tube is delivered to agraft receiving area through the oval-shaped openings of the hollowtube, the oval-shaped openings precluding the delivery of bone graftmaterial directly along the axis of the hollow tube, the plungerprecluded from rotating when inserted into the hollow tube; wherein theoval-shaped openings near the distal end of the hollow tube arepositioned within a 25% length from the distal end relative to a totallength of the hollow tube.

In one embodiment, a combination bone graft insertion and implantinsertion apparatus is disclosed, the apparatus comprising: a hollowtube constructed to receive bone graft, the hollow tube having anextended axis and a proximal end and a distal end, the hollow tubehaving a rectangular interior cross-section from the proximal end to thedistal end; a plunger adapted for inserting into the proximal end of thehollow tube along the extended axis, the plunger having a distal endexterior surface of rectangular cross-section contoured to the interiorcross-section of the hollow tube, the plunger with a distal exteriortip, the plunger distal end exterior surface of rectangularcross-section forming a substantially congruent fit with the hollow tuberectangular interior cross-section; and an expandable implant comprisinga first plate, a second plate, a front block, a rear block and a screw,the expandable implant configured to move the first plate verticallyfrom the second plate by rotation of the screw which rotates withoutmoving transversely with respect to either the first or the secondplate, the first plate and second plate moving in parallel upon rotationof the screw, the screw moving the front and the rear blocks so as tomove the first and the second plate, the blocks defining an aperture oneach lateral side of the expandable implant; wherein the hollow tube andthe plunger are configured to deliver bone graft material to theexpandable implant and to an adjacent surgical site through at least theapertures on each lateral side of the expandable implant.

In addition, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith, to include, withoutlimitation, expandable fusion cages: U.S. Pat. No. 4,863,476 toShepperd; U.S. Pat. No. 6,743,255 to Ferree; U.S. Pat. No. 6,773,460 toJackson; U.S. Pat. No. 6,835,206 to Jackson; U.S. Pat. No. 6,972,035 toMichelson; U.S. Pat. No. 7,771,473 to Thramann; U.S. Pat. No. 7,850,733to Baynham; U.S. Pat. No. 8,506,635 to Palmatier; U.S. Pat. No.8,556,979 to Glerum; U.S. Pat. No. 8,628,576 to Triplett; U.S. Pat. No.8,709,086 to Glerum; U.S. Pat. No. 8,715,351 to Pinto; U.S. Pat. No.8,753,347 to McCormack; U.S. Pat. No. 8,753,377 to McCormack; U.S.Design Pat. No. D708,323 to Reyes; U.S. Pat. No. 8,771,360 to Jimenez;U.S. Pat. No. 8,778,025 to Ragab; U.S. Pat. No. 8,778,027 to Medina;U.S. Pat. No. 8,808,383 to Kwak; U.S. Pat. No. 8,814,940 to Curran; U.S.Pat. No. 8,821,396 to Miles; U.S. Patent Application Publication No.2006/0142858 to Colleran; U.S. Patent Application Publication No.2008/0086142 to Kohm; U.S. Patent Application Publication No.2010/0286779 to Thibodean; U.S. Patent Application Publication No.2011/0301712 to Palmatier; U.S. Patent Application Publication No.2012/0022603 to Kirschman; U.S. Patent Application Publication No.2012/0035729 to Glerum; U.S. Patent Application Publication No.2012/0089185 to Gabelberger; U.S. Patent Application Publication No.2012/0123546 to Medina; U.S. Patent Application Publication No.2012/0197311 to Kirschman; U.S. Patent Application Publication No.2012/0215316 to Mohr; U.S. Patent Application Publication No.2013/0158664 to Palmatier; U.S. Patent Application Publication No.2013/0178940; U.S. Patent Application Publication No. 2014/0012383 toTriplett; U.S. Patent Application Publication No. 2014/0156006; U.S.Patent Application Publication No. 2014/0172103 to O'Neil; U.S. PatentApplication Publication No. 014/0172106 to To; U.S. Patent ApplicationPublication No. 2014/0207239 to Barreiro; U.S. Patent ApplicationPublication No. 2014/0228955 to Weiman; U.S. Patent ApplicationPublication No. 2014/0236296 to Wagner; U.S. Patent ApplicationPublication No. 2014/0236297 to Iott; U.S. Patent ApplicationPublication No. 2014/0236298 to Pinto.

Furthermore, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith, to include, withoutlimitation, expandable fusion cages: U.S. Pat. No. 7,803,159 toPerezCruet et al.; U.S. Pat. No. 8,852,282 to Farley et al.; U.S. Pat.No. 8,858,598 to Seifert et al.; U.S. Pat. No. D714,933 to Kawamura;U.S. Pat. No. 8,795,366 to Varela; U.S. Pat. No. 8,852,244 to Simonson;U.S. Patent Application Publication No. 2012/0158146 to Glerum et al.;U.S. Pat. No. 8,852,242 to Morgenstern Lopez et al.; U.S. Pat. No.8,852,281 to Phelps; U.S. Pat. No. 8,840,668 to Donahoe et al.; U.S.Pat. No. 8,840,622 to Vellido et al.; U.S. Patent ApplicationPublication No. 2014/0257405; U.S. Patent Application Publication No.2014/0257490 to Himmelberger et al.; U.S. Pat. No. 8,828,019 to Raymondet al.; U.S. Patent Application Publication No. 2014/0288652 to Boehm etal.; U.S. Patent Application Publication No. 2014/0287055 to Kunjachan;U.S. Patent Application Publication No. 2014/0276896 to Harper; U.S.Patent Application Publication No. 2014/0277497 to Bennett et al.; U.S.Patent Application Publication No. 2012/0029635 to Schoenhoeffer et al.;U.S. Patent Application Publication No. 2014/0303675 to Mishra; U.S.Patent Application Publication No. 2014/0303731 to Glerum; U.S. PatentApplication Publication No. 2014/0303732 to Rhoda et al.; U.S. Pat. No.8,852,279 to Weiman; PCT Pub. WO 2012/031267 to Weiman; U.S. Pat. No.8,845,731 to Weiman; U.S. Pat. No. 8,845,732 to Weiman; U.S. Pat. No.8,845,734 to Weiman; U.S. Patent Application Publication No.2014/0296985 to Balasubramanian et al.; U.S. Patent ApplicationPublication No. 2014/0309268 to Arnou; U.S. Patent ApplicationPublication No. 2014/0309548 to Merz et al.; U.S. Patent ApplicationPublication No. 2014/0309697 to Iott et al.; U.S. Patent ApplicationPublication No. 2014/0309714 to Mercanzini et al.; U.S. Pat. No.8,282,683 to McLaughlin et al.; U.S. Pat. No. 8,591,585 to McLaughlin etal; U.S. Pat. No. 8,394,129 to Morgenstern Lopez et al.; U.S. PatentApplication Publication No. 2011/0208226 to Fatone et al.; U.S. PatentApplication Publication No. 2010/0114147 to Biyani; U.S. PatentApplication Publication No. 2011/0144687 to Kleiner; U.S. Pat. No.8,852,243 to Morgenstern Lopez et al.; U.S. Pat. No. 8,597,333 toMorgenstern Lopez et al.; U.S. Pat. No. 8,518,087 to Lopez et al.; U.S.Patent Application Publication No. 2012/0071981 to Farley et al.; U.S.Patent Application Publication No. 2013/0006366 to Farley et al.; U.S.Patent Application Publication No. 2012/0065613 to Pepper et al.; U.S.Patent Application Publication No. 2013/0006365 to Pepper et al.; U.S.Patent Application Publication No. 2011/0257478 to Kleiner et al.; U.S.Patent Application Publication No. 2009/0182429 to Humphreys et al.;U.S. Patent Application Publication No. 2005/0118550 to Turri; U.S.Patent Application Publication No. 2009/0292361 to Lopez; U.S. PatentApplication Publication No. 2011/0054538 to Zehavi et al.; U.S. PatentApplication Publication No. 2005/0080443 to Fallin et al.; U.S. Pat. No.8,778,025 to Ragab et al.; U.S. Pat. No. 8,628,576 to Triplett et al;U.S. Pat. No. 8,808,304 to Weiman, and U.S. Pat. No. 8,828,019 toRaymond.

All of the following U.S. Patents are also incorporated herein byreference in their entirety: U.S. Pat. Nos. 6,595,998; 6,997,929;7,311,713; 7,749,255; 7,753,912; 7,780,734; 7,799,034; 7,875,078;7,931,688; 7,967,867; 8,075,623; 8,123,755; 8,142,437; 8,162,990;8,167,887; 8,197,544; 8,202,274; 8,206,395; 8,206,398; 8,317,802;8,337,531; 8,337,532; 8,337,562; 8,343,193; 8,349,014; 8,372,120;8,394,108; 8,414,622; 8,430,885; 8,439,929; 8,454,664; 8,475,500;8,512,383; 8,523,906; 8,529,627; 8,535,353; 8,562,654; 8,574,299;8,641,739; 8,657,826; 8,663,281; 8,715,351; 8,727,975; 8,828,019;8,845,640; 8,864,830; 8,900,313; 8,920,507; 8,974,464; 9,039,767;9,084,686; 9,095,446; 9,095,447; 9,101,488; 9,107,766; 9,113,962;9,114,026; 9,149,302; 9,174,147; 9,216,094; 9,226,777; 9,295,500;9,358,134; 9,381,094; 9,439,692; 9,439,783; 9,445,921; 9,456,830;9,480,578; 9,498,200; 9,498,347; 9,498,351; 9,517,140; 9,517,141;9,517,142; 9,545,250; 9,545,279; 9,545,313; 9,545,318; 9,610,175;9,629,668; 9,655,660; 9,655,743; 9,681,889; 9,687,360; 9,707,094;9,763,700; 9,861,395; 9,980,737; 9,993,353; U.S. Pat. Pub. 2014/0088712;U.S. Pat. Pub. 2014/0276581; U.S. Pat. Pub. 2014/0371721; U.S. Pat. Pub.2016/0296344; U.S. Pat. Pub. 2017/0367846; U.S. Pat. Pub. 2017/0354514.

One of ordinary skill in the art will appreciate that embodiments of thepresent disclosure may have various sizes. The sizes of the variouselements of embodiments of the present disclosure may be sized based onvarious factors including, for example, the anatomy of the implantpatient, the person or other device operating the apparatus, the implantlocation, physical features of the implant including, for example, with,length and thickness, and the size of operating site or the size of thesurgical tools being used with the device.

One or ordinary skill in the art will appreciate that embodiments of thepresent disclosure may be constructed of materials known to provide, orpredictably manufactured to provide the various aspects of the presentdisclosure. These materials may include, for example, stainless steel,titanium alloy, aluminum alloy, chromium alloy, and other metals ormetal alloys. These materials may also include, for example, PEEK,carbon fiber, ABS plastic, polyurethane, rubber, latex, syntheticrubber, and other fiber-encased resinous materials, synthetic materials,polymers, and natural materials. The plunger element could be flexible,semi-rigid, or rigid and made of materials such as stainless steel,titanium alloy, aluminum alloy, chromium alloy, and other metals ormetal alloys. Similarly, the tubular element could be flexible,semi-rigid, or rigid and made of materials such as stainless steel,titanium alloy, aluminum alloy, chromium alloy, and other metals ormetal alloys. In certain embodiments, the plunger and hollow tube arecomposed of plastic and are intended for one use only and thendiscarded. In another embodiment, some or all elements of the device, orportions of some or all of the elements, are luminescent. Also, inanother embodiment, some or all elements of the device, or portions ofsome or all of the elements, include lighting elements. In anotherembodiment, the hollow tube and/or plunger are made of a substantiallytransparent material and/or are rigidly opaque.

In one embodiment of the fusion cage, the fusion cage comprises apolymer, such as PEEK, titanium and composite materials.

One of ordinary skill in the art will appreciate that embodiments of thepresent disclosure may be controlled by means other than manualmanipulation. Embodiments of the present disclosure may be designed andshaped such that the apparatus may be controlled, for example, remotelyby an operator, remotely by an operator through a computer controller,by an operator using proportioning devices, programmatically by acomputer controller, by servo-controlled mechanisms, byhydraulically-driven mechanisms, by pneumatically-driven mechanisms orby piezoelectric actuators.

Embodiments of the present disclosure present several advantages overthe prior art including, for example, the speed of the procedure, theminimally invasive aspect of the procedure, the ability to introduce theimplant material to the implant site with minimal risk and damage to thesurrounding tissue, the lower risk of infection, more optimally placedimplant material, a more stable delivery device which is designed toreduce the likelihood of the implant material becoming dislodged priorto fixation, and fewer tools in a surgical site due to the integrationof several components required to provide bone graft to a bone graftreceiving area. Further, the lower profile of the device allows improvedviewing of the area intended for receipt of bone graft material, and useof a reduced set and size of elements therein provided a less expensivedevice. Also, the device disclosed provides that substantially all ofthe bone graft material may be ejected from the device and delivered tothe surgical site, rather than wasted as irretrievable matter remaininginside the device. The ability to remove substantially all of the bonegraft material is of significant benefit because the bone graft materialis expensive and/or hard to obtain.

This Summary of the Invention is neither intended nor should it beconstrued as being representative of the full extent and scope of thepresent disclosure. The present disclosure is set forth in variouslevels of detail in the Summary of the Invention as well as in theattached drawings and the Detailed Description of the Invention, and nolimitation as to the scope of the present disclosure is intended byeither the inclusion or non-inclusion of elements, components, etc. inthis Summary of the Invention. Additional aspects of the presentdisclosure will become more readily apparent from the DetailedDescription, particularly when taken together with the drawings.

The above-described benefits, embodiments, and/or characterizations arenot necessarily complete or exhaustive, and in particular, as to thepatentable subject matter disclosed herein. Other benefits, embodiments,and/or characterizations of the present disclosure are possibleutilizing, alone or in combination, as set forth above and/or describedin the accompanying figures and/or in the description herein below.However, the Detailed Description of the Invention, the drawing figures,and the exemplary claim set forth herein, taken in conjunction with thisSummary of the Invention, define the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the disclosure andtogether with the general description of the disclosure given above andthe detailed description of the drawings given below, serve to explainthe principles of the disclosures.

It should be understood that the drawings are not necessarily to scale.In certain instances, details that are not necessary for anunderstanding of the disclosure or that render other details difficultto perceive may have been omitted. It should be understood, of course,that the disclosure is not necessarily limited to the particularembodiments illustrated herein.

FIG. 1A is a front perspective view of a hollow tubular member of thedevice for delivering bone graft;

FIG. 1B is a front perspective view of the plunger of the device;

FIG. 1C is a cross sectional view of a portion of the device shown inFIG. 1A;

FIG. 2 is another front perspective view of the device of FIGS. 1A and1B, showing the relationship between the tubular and plunger portions ofthe device;

FIG. 3 is a front perspective view of the device according to onealternative embodiment where the tubular portion includes a foot sectionand where the plunger portion has been fully inserted into the tubularportion;

FIG. 4 is a partial front perspective view of another alternativeembodiment of the device where the tubular portion includes a funnel atits proximal end designed to receive bone graft;

FIG. 5 is a partial front perspective view of the device according toone embodiment where the device is positioned in a disc space during asurgical operation;

FIG. 6 is a front perspective view of one embodiment of the device,showing the relationship between the tubular and plunger portions wherethe tubular portion includes two lateral facing openings at the distalend of the tubular portion and a wedge-shaped distal end of the tubularmember;

FIG. 7 is another front perspective view of the tubular portion of thedevice of FIG. 6 showing the second of two lateral openings at thedistal end of the tubular portion and a wedge-shaped distal end of thetubular member;

FIG. 8 is a front elevation view of the distal end of the tubularportion of the device of FIG. 6;

FIG. 9 is a bottom elevation view of the proximal end of the tubulardevice of FIG. 6;

FIG. 10A is a top plan view of the device of FIG. 6 with the plungerportion fully inserted into the tubular portion;

FIG. 10B is a left elevation view of the device of FIG. 6 with theplunger portion fully inserted into the tubular portion;

FIG. 10C is a bottom plan view of the device of FIG. 6 with the plungerportion fully inserted into the tubular portion;

FIG. 10D is a right elevation view of the device of FIG. 6 with theplunger portion fully inserted into the tubular portion;

FIG. 11A is a front perspective view of one embodiment of the fusioncage of the device, showing a tapered proximal end and medial openings;

FIG. 11B is a top plan view of the fusion cage of FIG. 11A;

FIG. 11C is a left elevation view of the fusion cage of FIG. 11A;

FIG. 11D is a rear elevation view of the fusion cage of FIG. 11A;

FIG. 12A is a front perspective view of another embodiment of the fusioncage of the device;

FIG. 12B is a front perspective view of yet another embodiment of thefusion cage of the device;

FIG. 12C is a front perspective view of yet another embodiment of thefusion cage of the device;

FIG. 13 is a front perspective view of one embodiment of the device,showing the relationship between the tubular and plunger portions wherethe tubular portion includes two lateral facing openings at the distalend of the tubular portion and a wedge-shaped distal end of the tubularmember, and a fusion cage configured for fitting over the exteriordistal end of the tubular member;

FIG. 14A is a top plan view of the device of FIG. 13 with the plungerportion fully inserted into the tubular portion and the fusion cagefully inserted over the tubular portion;

FIG. 14B is a left elevation view of the device of FIG. 13 with theplunger portion fully inserted into the tubular portion and the fusioncage fully inserted over the tubular portion;

FIG. 14C is a bottom plan view of the device of FIG. 13 with the plungerportion fully inserted into the tubular portion and the fusion cagefully inserted over the tubular portion;

FIG. 14D is a right elevation view of the device of FIG. 13 with theplunger portion fully inserted into the tubular portion and the fusioncage fully inserted over the tubular portion;

FIG. 15A is a front perspective view of another embodiment of the fusioncage of the device;

FIG. 15B is a top plan view of another embodiment of the device whereinthe fusion cage of the device includes internal ramps and locking slotsconfigured to engage locking tabs of the tubular portion, and theplunger includes a tapered tip;

FIG. 15C is a left elevation view of the fusion cage of FIG. 15B;

FIG. 15D is a cross sectional view of the tubular portion taken alongline A-A of FIG. 15B;

FIG. 16 is a top plan view of another embodiment of the device with theplunger portion partially inserted into the tubular portion and thefusion cage engaged with the tubular portion via a break-off collar;

FIG. 17A is a top plan view of another embodiment of the device whereinthe fusion cage engages with a connector conduit which in turn engageswith the tubular portion;

FIG. 17B is a cross-sectional view of section A-A of FIG. 17A;

FIG. 18A is a top plan view of another embodiment of the device whereinthe tubular portion comprises a telescoping feature;

FIG. 18B is a left elevation view of the device of FIG. 18A;

FIG. 18C is a bottom plan view of the device of FIG. 18A;

FIG. 18D is a right elevation view of the device of FIG. 18A;

FIG. 19A is a top plan view of a fusion cage of an embodiment of thedevice particularly adapted for use in anterior lumbar interbody fusionprocedures;

FIG. 19B is a front elevation view of the device of FIG. 19A;

FIG. 19C is a left elevation view of the device of FIG. 19A;

FIG. 19D is a view of the device of FIG. 19A inserted between vertebrae;

FIG. 20A is a cross-sectional top plan view of a fusion cage of anembodiment of the device particularly adapted for use in direct lateralinterbody fusion procedures;

FIG. 20B is a front elevation view of the device of FIG. 20A;

FIG. 20C is a left elevation view of the device of FIG. 20A;

FIG. 20D is a view of the device of FIG. 20A inserted between vertebrae;

FIG. 21A is a front perspective view of a fusion cage of an embodimentof the device particularly adapted for use in connection withvertebrectomy procedures;

FIG. 21B is a left perspective view of the device of FIG. 21A;

FIG. 21C is a front elevation view of the device of FIG. 21A insertedinto a surgical site;

FIG. 21D is a left elevation view of the device of FIG. 21A insertedinto a surgical site;

FIG. 22 is a front perspective view of another embodiment of the devicefor delivering bone graft;

FIG. 23 is a front perspective exploded view of the device shown in FIG.22;

FIG. 24 is a top plan view of the device shown in FIG. 22;

FIG. 25 is a front elevation view of the device shown in FIG. 22;

FIG. 26 is a right elevation view of the device shown in FIG. 22;

FIG. 27 is a bottom plan view of the device shown in FIG. 22;

FIG. 28 is a cross-sectional view of section A-A of FIG. 25;

FIG. 29 is a front elevation view of the plunger element of the deviceshown in

FIG. 22;

FIG. 30 is a cross-sectional view of section B-B of FIG. 29;

FIG. 31 is a cross-sectional view of section C-C of FIG. 29;

FIG. 32 is a detailed front perspective view of a portion of the deviceshown in

FIG. 22;

FIG. 33 is a cross-sectional view of section D-D of FIG. 32;

FIG. 34A is a bar graph describing experimental results of bone graftdelivery and disk material removed for L4-5;

FIG. 34B is a bar graph describing experimental results of bone graftdelivery and disk material removed for L5-S1;

FIG. 35A is a table describing experimental results of bone graftdelivery and disk material removed;

FIG. 35B is a graph of the table of FIG. 35A describing experimentalresults of bone graft delivery and disk material removed;

FIG. 36 is a front perspective exploded view of an integrated fusioncage and graft delivery device according to another embodiment;

FIG. 37 is a front perspective view of the device of FIG. 36;

FIG. 38 is a close-up front perspective view of the device of FIG. 36;

FIG. 39 is a front perspective view of the ejection tool element of thedevice of FIG. 36;

FIG. 40 is a front perspective view of an integrated fusion cage andgraft delivery device according to yet another embodiment;

FIG. 41 is a close-up front perspective view of the device of FIG. 40;

FIG. 42 is a close-up front perspective view of the ejection toolelement first end;

FIG. 43 is a cut-away cross-sectional view of the element of FIG. 42;

FIG. 44 is a close-up cut-away cross-sectional view of one embodiment ofthe integrated fusion cage and graft delivery device;

FIGS. 45A-G provide scaled views of one embodiment of the fusion cageelement of yet another embodiment of the integrated fusion cage andgraft delivery device configured to operate with the hollow tube ofFIGS. 46A-H, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E;

FIGS. 46A-H provide scaled views of one embodiment of the hollow tube(aka snap on cannula) of the integrated fusion cage and graft deliverydevice configured to operate with the fusion cage element of FIGS.45A-G, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E;

FIGS. 47A-D provide scaled views of one embodiment of the plunger (akasnap on plunger) of the integrated fusion cage and graft delivery deviceconfigured to operate with the fusion cage element of FIGS. 45A-G,hollow tube of FIGS. 46A-H, and ejection tool of FIGS. 48A-E;

FIGS. 48A-E provide scaled views of one embodiment of the ejection tool(aka cage insertion tool) of the integrated fusion cage and graftdelivery device configured to operate with the fusion cage element ofFIGS. 45A-G, hollow tube of FIGS. 46A-H and plunger of FIGS. 47A-D;

FIG. 49A is a left perspective view of an embodiment of the fusion cagewith expandable fusion cage feature, the fusion cage in an unexpandedstate;

FIG. 49B is a rear perspective view of the device shown in FIG. 49A;

FIG. 49C is a top perspective view of the device shown in FIG. 49A;

FIG. 50A is a left perspective view of the device shown in FIG. 49A, thefusion cage in an expanded state;

FIG. 50B is a rear perspective view of the device shown in FIG. 50A;

FIG. 50C is a top perspective view of the device shown in FIG. 50A;

FIG. 51 is a scaled rear perspective exploded view of an embodiment ofthe fusion cage with expandable fusion cage feature;

FIGS. 52A-E provide scaled views of the device shown in FIG. 51, thefusion cage in an unexpanded state;

FIGS. 53A-E provide scaled views of the device shown in FIG. 51, thefusion cage in an expanded state;

FIGS. 54A-F provide scaled views of the upper plate component of thedevice shown in FIG. 51;

FIGS. 55A-E provide scaled views of the front block component of thedevice shown in FIG. 51;

FIGS. 56A-F provide scaled views of the rear block component of thedevice shown in FIG. 51;

FIGS. 57A-C provide scaled views of the expansion screw component of thedevice shown in FIG. 51;

FIG. 58 is a rear perspective exploded view of another embodiment of thefusion cage with expandable fusion cage feature;

FIGS. 59A-E provide scaled views of the device shown in FIG. 58, thefusion cage in an unexpanded state;

FIGS. 60A-E provide scaled views of the device shown in FIG. 58, thefusion cage in an expanded state;

FIG. 61A is a front left perspective view of yet another embodiment ofthe fusion cage with expandable fusion cage feature, comprising avertical wedge angle feature;

FIG. 61B is a left elevation view of the device of FIG. 61A;

FIG. 62A is a front left perspective view of yet another embodiment ofthe fusion cage with expandable fusion cage feature, comprising ahorizontal wedge angle feature;

FIG. 62B is a left elevation view of the device of FIG. 62A;

FIG. 63A is a left rear perspective view of a fusion cage withexpandable fusion cage feature configured to communicate with aninstaller/impactor component according to yet another embodiment;

FIG. 63B is a close-up partial left rear perspective view of the devicesof FIG. 63A;

FIG. 64 is a left rear perspective view of the rear block component ofthe fusion cage of FIG. 63A;

FIG. 65A is a left rear perspective view of the devices of FIG. 63A,shown with the fusion cage and installer/impactor components in anengaged state, and the installer/impactor comprising aninstaller/impactor handle;

FIG. 65B is a left front perspective partial cross-sectional view of thedevices of FIG. 63A in the state of FIG. 65A, shown with the fusion cageand installer/impactor components in an engaged state, the devicesengaged with an expansion driver component, the installer/impactorcomponent shown in partial cross-section to partially show the expansiondriver fitted within the interior of the installer/impactor;

FIG. 66 is a left front perspective view of the devices of FIG. 63A,shown with the fusion cage and installer/impactor components in anengaged state, with the hollow tube component engaged with theinstaller/impactor component;

FIG. 67 is a left rear perspective view of the devices of FIG. 63A,shown with the fusion cage and installer/impactor components in anengaged state, and shown with the fusion cage and hollow tube in anengaged state;

FIG. 68A is a left rear perspective view of the devices of FIG. 63A,shown in the configuration of FIG. 67, with a removal pliers componentengaged with the hollow tube component;

FIG. 68B is a close-up partial perspective view of the devices of FIG.68A;

FIG. 69 is a left rear exploded perspective view of a fusion cage withexpandable fusion cage feature engaged with a hollow tube component anda funnel component, as configured to engage with a plunger component;

FIG. 70 is a left front partial perspective view of another embodimentof the hollow tube component configured to engage a fusion cage withexpandable fusion cage feature, the hollow tube configured with hollowtube slot and hollow tube slot aperture features;

FIG. 71 is a left rear perspective view of another embodiment of thelower plate component of a fusion cage with expandable fusion cagefeature, the lower plate configured with a plate tab feature configuredto engage the hollow tube slot and hollow tube slot aperture features ofFIG. 70;

FIG. 72 is a left front partial cross-section perspective view of thedevices of FIGS. 70 and 71, shown with the plate tab feature engagedwith the hollow tube slot and hollow tube slot aperture features;

FIG. 73 is a right rear exploded view of another embodiment of thefusion cage with expandable cage feature;

FIG. 74 depicts the fusion cage with expandable cage feature engagedwith an angled insertion tool;

FIG. 75A is a perspective view of a device for delivering bone graft ofanother embodiment illustrating a hollow tubular member including aplurality of vent ports and a plunger of an embodiment of the presentdisclosure;

FIG. 75B is a top plan view of the hollow tubular member of FIG. 75A anddetachable funnel;

FIG. 75C is a side elevation view of the hollow tubular member of FIG.75A interconnected to the funnel and including a plunger inserted into alumen of the hollow tubular member;

FIG. 75D is a front elevation view of the hollow tubular member of FIG.75A and illustrating an optional opening at the distal end;

FIG. 75E is an expanded cross sectional view of a portion of the hollowtubular member;

FIG. 76A is a cross-sectional view of a surgical site and a bone graftdelivery device according to one embodiment of the present disclosure;

FIG. 76B is another cross-sectional view of the surgical site of FIG.76A after the bone graft delivery device has been removed therefrom;

FIG. 77 is a side perspective view of another embodiment of a device fordelivering bone graft;

FIG. 78 is a side perspective view of still another integrated fusioncage and graft delivery device of the present disclosure;

FIG. 79 is a longitudinal cross-sectional view of a graft deliverydevice of the present disclosure;

FIG. 80 is a perspective view of an exterior of a graft delivery deviceof the present disclosure;

FIG. 81 is a transverse cross-sectional view of a graft delivery deviceof the present disclosure;

FIGS. 82A and 82B are perspective and transverse cross-sectional views,respectively, of one embodiment of an interconnection between a proximalinterior tube and a breech area of a graft delivery device of thepresent disclosure; and

FIGS. 83A and 83B are longitudinal cross-sectional and perspectiveviews, respectively, of a locking mechanism for securely interconnectinga distal tube, a proximal interior tube, and a breech area of a graftdelivery device of the present disclosure.

To provide further clarity to the Detailed Description provided hereinin the associated drawings, the following list of components andassociated numbering are provided as follows:

Reference No. Component  1 Integrated fusion cage and graft deliverydevice  2 Hollow tube  3 Hollow tube first (side) exterior surface  4Opening (of Hollow tube)  5 Hollow tube second (top) exterior surface  6First (or proximal) end (of Hollow tube)  6A Knob  6B Pin  7 Hollow tubefirst distal opening  8 Second (or distal) end (of Hollow tube)  8AHollow tube cage clamp  8B Hollow tube cage clamp radial surface  9Hollow tube distal interior ramp  9A Hollow tube distal interior rampsurface  10 Curved surface (of Hollow tube)  10A Curved interior surface(of Hollow tube)  11 Footing (of Hollow tube)  12 Plunger  13 Plungerdistal first surface  14 Plunger distal second surface  15 Plungerdistal third surface  16 Handle (of Plunger)  16A Plunger stop  17Plunger medial portion  18 Second (or distal) end (of Plunger)  18APusher  19 Horizontal surface (of Plunger)  20 Curved surface (ofPlunger)  21 Vent port  22 First portion  23 Second portion  24 Joint orplane  25 Peg or pin  26 Recess  27 Teeth or notches of plunger  28Lumen  29 Indicia to indicate depth of insertion of distal end  30Funnel  32 Sleeve (of Funnel)  33 Slot for pin of bayonet mount  34Opening (of Funnel)  35 Vent channel in plunger pusher  36 Endoscope,camera, or image sensing device  37 Lighting element  40 Disc space  42Syringe  44 Bone graft material  46 Luer lock device  48 Bore  50Wedge-shaped Second end (of Hollow tube)  52 Wedge-shaped Second end (ofPlunger)  60 Fusion Cage  61 Fusion cage surface texture  62 Fusion CageFirst (or Proximal) End  64 Fusion Cage Second (or Distal) End  65Fusion Cage First Opening Pair  66 Fusion Cage First End Opening  67Fusion Cage Second Opening Pair  68 Fusion Cage Medial Opening  69Fusion Cage Lateral Opening  70 Fusion Cage Medial Surfaces  72 FusionCage Internal Ramps  80 Hollow Tube Locking Tabs  82 Fusion Cage LockingSlots  90 Break-off Collar  92 Fusion Cage Collar  93 Fusion Cage CollarFace  94 Fusion Cage Collar Cavity  96 Fusion Cage Tab Extension  97Fusion Cage Tab Extension Latch 100 Connector Conduit 102 Connectors 110ALIF Fusion Cage 112 ALIF Fusion Cage Portals 114 ALIF Fusion CageChamber 116 ALIF Fusion Cage Break-off Collar 120 D-LIF Fusion Cage 122D-LIF Fusion Cage Portals 124 D-LIF Fusion Cage Chamber 126 D-LIF FusionCage Break-off Collar 130 Vertebrectomy Fusion Cage 132 VertebrectomyFusion Cage Porous Wall Portion 134 Vertebrectomy Fusion Cage Chamber136 Vertebrectomy Fusion Cage Break-off Collar 138 Vertebrectomy FusionCage Impervious Wall Portion 140 Ejection Tool 142 Ejection Tool First(Proximal) End 143 Ejection Tool Stop 144 Ejection Tool Cover 145Ejection Tool Cover Cavity 146 Spring Cover 147 Spring Cover Attachment148 Spring 149 Ejection Tool Wings 150 Ejection Tool Wings Cavity 151Ejection Tool L-cut 152 Ejection Tool Second (Distal) End 160 EjectionTool Rod 170 Bone graft deliver device 171 Spine 172 Surgical site 174Path for fusion cage 200 Upper Plate 201 Upper Plate Front 202 UpperPlate Rear 203 Upper Plate Openin 204 Upper Plate Surface Texture 205Upper Plate Track 206 Upper Plate Slot 209 Upper Plate Ridge 210 LowerPlate 211 Lower Plate Front 212 Lower Plate Rear 213 Lower Plate Opening214 Lower Plate Surface Texture 215 Lower Plate Track 216 Lower PlateSlot 217 Plate Tab 218 Plate Nose 219 Lower Plate Ridge 220 Front Block222 Front Block Upper Rail 224 Front Block Lower Rail 225 Front BlockNose 226 Front Block Ramp 227 Front Block Aperture 228 Block Spine 230Rear Block 231 Rear Block Groove 232 Rear Block Upper Rail 234 RearBlock Lower Rail 236 Rear Block Ramp 237 Rear Block Aperture 238 RearBlock Aft 239 Rear Block Detent 240 Expansion Screw 242 Expansion ScrewHead 244 Expansion Screw Tip 246 Expansion Screw Disk 250Installer/Impactor 252 Installer/Impactor Tip 253 Installer/ImpactorAperture 254 Installer/Impactor Ridge 255 Installer/Impactor Channel 256Installer/Impactor Ramp 258 Installer/Impactor Handle 260 ExpansionDriver 268 Expansion Driver Handle 270 Removal Pliers 280 Hollow TubeExternal Ramp 282 Hollow Tube Notch 284 Hollow Tube Slot 285 Hollow TubeSlot Aperture 290 Cam 292 Nose Cone 294 Ramps 300 Adaptor 304 Grip 306Trigger 308 Handle 310 Knob 312 Switch or button 314 Loading port 316Capsule or package of bone graft material 318 Knob of grip 320 Flange322 Slot 324 Channel 326 Proximal opening of channel 400 Prior ArtFusion Cage 400′ Modified Prior Art Fusion Cage 501 Distal tube 502Proximal interior tube 503 Breech area 504 Breech hinge 505 Breech lock506 Vertically extending rail α Vertical Wedge Angle β Horizontal WedgeAngle

DETAILED DESCRIPTION

The present invention relates to a device and method for integrated andnear-simultaneous delivery of bone graft material and a fusion cage toany portion of a patient which requires bone graft material and/or afusion cage. Thus, for example, the foregoing description of the variousembodiments contemplates delivery to, for example, a window cut in abone, where access to such window for bone grafting is difficult toobtain because of orientation of such window, presence of muscle tissue,risk of injury or infection, etc. The integrated fusion cage and graftdelivery device is formed such that the one or more hollow tubes and/orplungers may be helpful in selectively and controllably placing bonegraft material and a fusion cage in or adjacent to such window. Theintegrated fusion cage and graft delivery device is formed to allowdelivery of bone graft material and/or a fusion cage in a directionother than solely along the longitudinal axis of the device, and in someembodiments transverse to the primary axis used by the surgeon oroperator of the device when inserting the device into a cannula or otherconduit to access the surgical site. This same concept applies to otherareas of a patient, whether or not a window has been cut in a bone, forexample in a vertebral disc space, and may be used whether this is afirst surgery to the area or a follow-up surgery. The present inventionalso contemplates the delivery of bone graft material and/or a fusioncage with or without the use of a plunger, and with or without the useof various other tools described in greater detail herein.

Referring now to FIGS. 1-33 and 36-45, several embodiments of thepresent invention are shown.

In regard to FIG. 1A, an integrated fusion cage and graft deliverydevice portion is shown, which is comprised of a hollow tubular memberor hollow tube or contains at least one inner lumen 2, which has a firstproximate end 6 (which is referred to elsewhere in this specification asthe “graspable end” of hollow tube 2), and a second distal end 8, with ageneral hollow structure therebetween. Thus, as shown in FIG. 1, thehollow tube 2 allows bone graft material to be inserted into the opening4 at the graspable end 6 of the hollow tube 2, and ultimately exitedfrom the hollow tube 2 through the second end 8. According to apreferred embodiment, the hollow tube 2 also comprises at least onesloped or curved surface 10 at or near the second end 8 of the hollowtube 2. Although a generally rectangular cross-section is depicted, thecross-section need not be limited to a generally rectangular shape. Forexample, cross-sections of an oval shape or those with at least onedefined angle to include obtuse, acute, and right angles can provide ashape in some situations that is more congruent with the size or shapeof the annulotomy of a particular disc space.

Referring now in detail to FIG. 1B, a plunger 12 is shown for use withthe hollow tube 2 of FIG. 1A. The plunger 12 is generally of the samegeometry as the hollow portion of the hollow tube 2, extending at leastthe same length of hollow tube 2. The plunger 12 may include, asdepicted in FIG. 1B, at least one knob or handle 16 for grasping by auser of the plunger 12. As with the interior of the hollow tube 2 at itssecond end 8, the plunger 12 also comprises at least one sloped orcurved surface 20 at or adjacent to a second end 18 of the plunger 12.The plunger 12 terminates in a generally flat, horizontal surface 19,which corresponds to the opening at the second end 8 of the hollow tube2 shown in FIG. 1A. Thus, in cooperation, the plunger 12 may be insertedinto the opening 4 of the hollow tube 2 shown in FIG. 1A, and extendedthe entire length of the hollow tube 2, at least to a point where thehorizontal surface 19 of plunger 12 is in communication with the secondend 8 of the hollow tube 2. This configuration permits a user to ejectsubstantially all of the bone graft material that is placed into thehollow tube 2 during a surgical procedure. One skilled in the art willappreciate that the plunger need not terminate in a generally flat,horizontal surface to affect the substantial removal of all of the bonegraft material placed into the hollow tube; more specifically, any shapethat allows conformance between the internal contour of the distal endof the hollow tube and the distal end of the plunger will affect thesubstantial removal of the bone graft material. Further details aboutthe relationship are described below in regard to FIG. 2.

In the embodiment, of FIG. 1A-C, a contoured leading edge is provided onthe plunger 12 to correspond with the internal contour of distal end 8of the hollow tube 2 of the delivery device. This contoured plungerserves several purposes: First, it maintains the plunger in a desirablerotational position with respect to the hollow tube (i.e., prevents theplunger from inadvertently or intentionally being manipulated to rotateabout the longitudinal axis of the hollow tube). Second, it ensures thatwhen the plunger is fully inserted, the plunger removes substantiallyall of the bone graft material from the hollow tube. Also, the contouredplunger, corresponding to the contoured tubular member, allows immediateidentification of the orientation of the device, and more specificallythe direction of eject of the bone graft material into the surgicalarea. Alternative positioning means may also be provided to ensure thatthe plunger remains in the desirable position during delivery of bonegraft into the hollow tube, for example by a machined bevel or edge onthe outer surface of the plunger, and a corresponding groove in theinterior surface of the hollow tube, which must be aligned wheninserting the plunger in the hollow tube.

Referring now to FIG. 1C, an elevation view of the hollow tube 2 shownin FIG. 1A is shown in detail. The second end 8 of the hollow tube 2 hasan opening with a height A and width B according to the needs of thesurgeon, the location of the bone graft receiving area, the nature ofthe surgical operation to be performed, and the quantity and type ofbone graft that is being inserted in (and ultimately ejected from) thisintegrated fusion cage and graft delivery device. According to apreferred embodiment, the height A of the opening at the second end 8 ofthe hollow tube 2 is in the range of 4 mm to 9 mm, and in a mostpreferred embodiment is about 7 mm. According to a preferred embodiment,the width B of the opening at the second end 8 of the hollow tube 2 isin the range of 7 mm to 14 mm, and in a most preferred embodiment isabout 10 mm.

Referring to FIGS. 1A-C, it is to be understood that although theseparticular drawings reflect an embodiment where the second end 8 of thehollow tube 2, and the second end 18 of the plunger 12 comprise a curvedor sloped surface which extends at least a certain distance laterallyaway from the generally longitudinal axis of the hollow tube 2/plunger12, that in other embodiments, the second end 8 of the hollow tube 2(and thereby, the second end 18 of the plunger 12) do not extend alateral distance away, but rather terminate along the longitudinal wallof the hollow tube 2. In this embodiment, the hollow tube 2 may have asecond end 8 which has an opening that is carved out of the side of thewall of the hollow tube 2, such that it appears as a window in thetubular body of hollow tube 2. According to this embodiment, thehorizontal face 19 of the plunger 12 would also be a face on the outersurface of plunger 12, without extending any lateral distance away fromthe body of plunger 12. According to this embodiment, the plunger 12would still retain the curved or sloped surface at the opposite end ofthe horizontal face 19 (referred to in FIG. 1B as 20) and similarly thehollow tube 2 would still comprise a sloped or curved surface 10opposite the opening at second end 8. It is to be expressly understoodthat other variations which deviate from the drawing FIGS. 1A-C are alsocontemplated with the present invention, so long as that the opening atthe second end 8 of hollow tube 2 is oriented to permit bone graft to beexited from the hollow tube 2 in a generally lateral direction (inrelation to the longitudinal direction of the axis of the hollow tube2).

According to another embodiment, the plunger 12 shown in FIG. 1B mayfurther comprise a secondary handle (not shown in FIG. 1B), whichincludes an opening about at least one end of secondary handle such thatit is permitted to couple with handle 16 of plunger 12. In this fashion,the secondary handle may be larger, contain one or more rings orapertures for placing a user's hand and/or fingers, or may simply be ofa more ergonomic design, for accommodating use of the plunger 12 duringa surgical operation. The secondary handle, according to thisembodiment, is selectively removable, which permits a surgeon to use thesecondary handle for inserting the plunger 12, and then at a later pointremove the secondary handle, for instance, to improve visibility throughthe incision or through the hollow tube 2, and/or to determine whethersubstantially all of the bone graft material has been ejected from thehollow tube 2.

Referring now in detail to FIG. 2, the plunger 12 is shown inserted intothe hollow tube 2, such that the horizontal face 19 is substantiallyplanar with the opening at the second end 8 of the hollow tube 2. Asdescribed above, the geometry of plunger 12 is such that it fits snugglyor tightly in the interior of the hollow tube 2. This configuration issuch that the sloped or curved surface 10 of the hollow tube 2 issubstantially congruent to the sloped or curved surface 20 of theplunger (not shown in FIG. 2), thereby allowing the plunger to beinserted into the hollow tube 2 and allowing substantially all of bonegraft material which is placed into the hollow tube 2 to be ejected bythe user.

Referring now in detail to FIG. 3, an alternate embodiment of thepresent invention is shown. According to this embodiment, the hollowtube 2 comprises a footing 11 at the second end 8 of the hollow tube 2.This footing 11 extends in a lateral direction, opposite the directionof the opening at the second end 8 of the hollow tube 2. The purpose ofthis footing 11 is to prevent injury to the annulus of a patient, orother sensitive anatomy adjacent the bone graft receiving area. Thisfooting 11 is helpful when a surgeon or other user of the integratedfusion cage and graft delivery device is using the plunger 12 to drivebone graft through the hollow tube 2, or using another tool, such as atamp, mallet, or other driving or impacting device to strike the plunger12 and/or hollow tube 2 during the surgical procedure. Without thefooting 11, the hollow tube 2 would have a generally angular second end8, which may cause damage to the patient during these types ofprocedures. Thus, the footing 11 prevents the second end 8 of the hollowtube 2 from penetrating the annulus or other sensitive anatomy of thepatient.

According to this embodiment, the footing 11 may also operate to ensurea fixed position of the second end 8 of the hollow tube 2 in thesurgical site. This in turn allows a user to ensure that bone graftejecting the second end 8 of the hollow tube 2 is being ejectedlaterally, and in the desired direction. This may be important, forexample, when the integrated fusion cage and graft delivery device isplaced within a disc space, and bone graft is being ejected laterallyfrom the second end 8 of the hollow tube 2 in a specific direction. Inother embodiments, the footing 11 may also serve as a visual marker forthe surgeon, as it extends away from the horizontal wall of the hollowtube 2, and is therefore visible at the second end 8 of the hollow tube2. As shown in FIG. 3, the presence of the footing 11 does not affectthe interior slope or curved surface 10A of the hollow tube 2, so thatthe plunger 12 of the design shown in FIG. 1B may still be used with thehollow tube 2 of this alternate embodiment.

Referring now in detail to FIG. 4, a removable funnel 30 is shown, whichcomprises an opening 34 which is generally larger in diameter ordimension when compared to the opening 4 of the hollow tube 2. Thisremovable funnel 30 further comprises a sleeve 32, the sleeve 32 havingan internal cross-section which is substantially congruent with theexternal cross-section of the first end 6 of the hollow tube 2. Thus,according to this embodiment, the funnel 30 is selectively removablefrom the first end 6 of the hollow tube 2, and may allow a surgeon tomore easily place new or additional bone graft into the hollow tube 2 byway of the opening 34 of the funnel 30. This funnel 30 may be used inconnection with a hollow tube 2 that has been pre-filled with bonegraft, or a hollow tube which is not pre-filled with bone graft. Thus,the funnel may be selectively positioned on the first end 6 of thehollow tube 2 at any point during the surgical operation when thesurgeon desires new or additional bone graft be placed in the hollowtube 2 of the integrated fusion cage and graft delivery device.

Referring now in detail to FIG. 5, one particular application of theintegrated fusion cage and graft delivery device is shown in aperspective view. Here, the integrated fusion cage and graft deliverydevice is shown with the embodiment of the hollow tube 2 furthercomprising a footing 11, and a second end opening for ejecting bonegraft in a generally lateral direction, here in the interior of a discspace 40. The disc is shown with an opening on one end for inserting thesecond end 8 of the hollow tube 2 of the integrated fusion cage andgraft delivery device. As opposed to prior art integrated fusion cageand graft delivery devices which have an opening at a second end that isopen to the longitudinal axis of the delivery device, the presentinvention comprises a lateral opening, which as shown in FIG. 5 allows asurgeon to eject bone graft material into the lateral direction andthereby into the opened areas of the disc space 40. A surgeon has theoption to rotate the direction of the opening in the second end 8 of thehollow tube 2 for ejecting additional bone graft to other open areas inthe disc space 40. Once the disc space 40 is substantially full of bonegraft, the surgeon may remove the hollow tube 2 without disturbing thedisc or anatomy of the patient.

The surgeon may also accomplish the delivery of bone graft withoutdisplacing any cage or other structural implantable device which may bepresent in or adjacent the disc space. One skilled in the art willappreciate that the hollow tube 2 further comprising a footing 11, and asecond end opening for ejecting bone graft in a generally lateraldirection, may affect the delivery of bone graft in a lateral directionsimultaneous with delivery in a longitudinal direction.

Referring now to FIGS. 6-10, a preferred embodiment of the device isshown. In regard to FIG. 6, an integrated fusion cage and graft deliverydevice portion is shown, comprised of a hollow tubular member 2, whichhas a first proximate end 6 and a second distal end 8, with a generalhollow structure therebetween. The generally hollow tube 2 is shown withone of two lateral openings at the distal end 8 of the tubular member 2viewable (the other is viewable in FIG. 7). Also in FIG. 6, the plungermember 12 is shown. The manner of insertion of plunger member 12 intotubular member 2 is also provided. Thus, as shown in FIG. 6, the hollowtube 2 allows bone graft material to be inserted into the opening 4 atthe proximal end 6 of the hollow tube 2, and ultimately exited from thehollow tube 2 through the second distal end 8 from the lateral openingsat the distal end 8 of the hollow tubular member 2.

Furthermore, regarding FIG. 6, a preferred embodiment of the distal end8 of the tubular member 2 and the distal end 18 of the plunger member 12is provided. The configuration provided, a wedge-shaped end 50 of thetubular member 2 and a wedge-shaped end 52 of the plunger 12, allowssubstantially all of the bone graft material to be removed and thusinserted into the surgical area when the plunger 12 is fully insertedinto the tubular member 2. The wedge-shaped feature 50 of the distal end8 of the tubular member 2 and the wedge-shaped end 52 of the distal end18 of the plunger member 12 is discussed in additional detail withrespect to FIGS. 8 and 9 below. The ability to remove substantially allof the bone graft material is an important feature of the inventionbecause bone graft material is traditionally expensive and may requiresurgery to obtain.

Referring now to FIG. 7, a perspective view of a preferred embodiment ofthe hollow tubular member 2 is provided. Consistent with FIG. 6, thegenerally hollow tube 2 is shown with one of two lateral openings at thedistal end 8 of the tubular member 2 viewable (the other is viewable inFIG. 6). Thus, in operation the hollow tube 2 allows bone graft materialto be inserted into the opening 4 at the proximal end 6 of the hollowtube 2, and ultimately exited from the hollow tube 2 through the seconddistal end 8 from the lateral openings at the distal end 8 of the hollowtubular member 2. In this configuration, bone graft material is ejectedinto the surgical area in two lateral directions. One skilled in the artwill appreciate that the openings at the distal end 8 of the hollowtubular member 2 need not be positioned exclusively on one or morelateral sides of the distal end 8 of the tubular member to allow bonegraft material to be provided to the surgical site in other than apurely axial or longitudinal direction. Further, one skilled in the artwill appreciate that the specific absolute and relative geometries andnumbers of lateral openings may vary, for example the distal end 8 ofthe tubular member 2 may have more than two openings that are ofdifferent shape (e.g. oval, rectangular).

Referring now to FIG. 8, an elevation view of the wedge-shaped distalend 50 of the tubular member 2 is provided. In this embodiment, thedistal end 52 of the plunger 12 would conform to the same shape, toallow close fitting of the plunger and the hollow tubular member. Thiscontoured plunger, corresponding to the contoured tubular member, servesseveral purposes: First, it maintains the plunger in a desirablerotational position with respect to the hollow tube (i.e., prevent theplunger from inadvertently or intentionally being manipulated to rotateabout the longitudinal axis of the hollow tube); Second, it ensures thatwhen the plunger is fully inserted, the plunger removes substantiallyall of the bone graft material from the hollow tube. Also, the contouredplunger, corresponding to the contoured tubular member, allows immediateidentification of the orientation of the device, and more specificallythe direction of eject of the bone graft material into the surgicalarea. One skilled in the art will appreciate that the plunger 12 neednot terminate in a wedge-shape surface 52 to affect the substantialremoval of all of the bone graft material placed into the hollow tube 2;more specifically, any shape that allows conformance between theinternal contour of the distal end of the hollow tube and the distal endof the plunger will affect the substantial removal of the bone graftmaterial.

Referring now to FIG. 9, an elevation view of the opening 4 of theproximal end 6 of the hollow tubular member 2 is provided. As shown inFIG. 9, the opening 4 at the proximal end 6 of the hollow tube 2 allowsdeposit of bone graft material. In this configuration, the cross-sectionof the opening 4 at the proximal end 6 of the hollow tube 2 is generallysquare. Although a generally square cross-section is depicted, thecross-section need not be limited to a generally square shape. Forexample, cross-sections of an oval shape or those with at least onedefined angle to include obtuse, acute, and right angles can provide ashape in some situations that is more congruent with the size or shapeof the annulotomy of a particular disc space.

Referring to FIGS. 10A-D, sequential elevation views of thesquare-shaped embodiment of the integrated fusion cage and graftdelivery device 1 are provided, depicting the complete insertion of theplunger 12 into the hollow tubular member 2. In each of FIGS. 10A-D, thewedge-shaped distal end 50 of the tubular member 2 is depicted. Also,each of FIGS. 10A-D depict the additional length of the plunger element12 when inserted into the tubular member 2. FIG. 10A shows one of twolateral openings at the distal end 8 of the hollow tubular member 2.FIG. 10C shows another of the two lateral openings at the distal end 8of the hollow tubular member 2. One skilled in the art will appreciatethat the openings at the distal end 8 of the hollow tubular member 2need not be positioned exclusively on one or more lateral sides of thedistal end 8 of the tubular member to allow bone graft material to beprovided to the surgical site in other than a purely axial orlongitudinal direction. Further, one skilled in the art will appreciatethat the specific absolute and relative geometries and numbers oflateral openings may vary, for example the distal end 8 of the tubularmember 2 may have more than two openings that are of different shape(e.g. oval, rectangular).

Referring to FIGS. 11A-D, a fusion cage 60 of an integrated fusion cageand graft delivery device 1 portion is shown, which is comprised of anintegrated fusion cage 60 that comprises a first proximal end 62 and asecond distal end 64 wherein the first proximal end contains an opening66 adapted to allow fitting and/or engagement to the distal end 8 of thehollow tube 2. This fitting and/or engagement may be over the externalsurface of the hollow tube 2 or inside the interior of the hollow tube2. Further, the integrated fusion cage 60 may comprise one or moremedial openings 68 that align with one or more openings at the distalend 8 of the hollow tube 2. Further, the integrated fusion cage 60 maycontain non-smooth surfaces, such as belts or striations, along one ormore medial surfaces 70 of the integrated fusion cage 60. The integratedfusion cage 60 is configured such that when a plunger 12, once fullyinserted in to the hollow tube 2, is substantially congruent with thehollow interior portion of the hollow tube 2, e.g. both the plunger 12and the hollow tube 2 are substantially the same shape and/or class andbone graft material is delivered through the integrated fusion cage 60into the surgical area.

In a preferred embodiment, the fusion cage 60 has a tapered tip, andseveral open channels along the medial and lateral surfaces. In apreferred embodiment, the fusion cage 60 and/or the bone graft deliveryportion of the integrated fusion cage and graft delivery device is ofoblong or rectangular or square shape. The integrated fusion cage andgraft delivery device 1 is designed to avoid blocking or impacting bonegraft material into a surgical disc space, thereby limiting the bonegraft material that may be delivered, and not allowing available fusionspace to be fully exploited for fusion.

In a preferred embodiment, the fusion cage 60 has a keel-shaped tip toseparate disk and prevent annular penetration. Also, the fusion cage 60may have dual portals for bone graft

discharge, with the medial openings 68 larger than the lateral openings69. Further, the fusion cage may be designed in variable heights andlengths so that it fits snugly into the prepared disk space.

Referring now to FIGS. 12A-C, two alternate embodiments of the fusioncage 60 are provided. FIG. 12A shows an embodiment of the integratedfusion cage 60 with a second distal end 64 tapered to a flat rectangularshaped end. FIG. 12B shows an embodiment of the integrated fusion cage60 with a second distal end 64 tapered to a wedged-shaped end. Such aconfiguration would be, for example, conformal with the wedge-shapedsecond end 50 of the hollow tube 2, as shown in FIGS. 6-8. FIG. 12Cshows an embodiment of the integrated fusion cage 60 with belts ofstriations imparted to the upper medial surface 70 of the fusion 20 cage60.

In regard to FIG. 13, an integrated fusion cage and graft deliverydevice 1 is shown, comprised of a hollow tubular member 2, which has afirst proximate end 6 and a second distal end 8, with a general hollowstructure therebetween. The generally hollow tube 2 is shown with one oftwo lateral openings at the distal end 8 of the tubular member 2viewable. Also in FIG. 13, the plunger member 12 is shown and the fusioncage 60. The manner of insertion of plunger member 12 into tubularmember 2 is also provided, as is the manner of insertion of fusion cage60 over tubular member 2 and into the fusion cage first end opening 66.Thus, as shown in FIG. 13, the hollow tube 2 allows bone graft materialto be inserted into the opening 4 at the proximal end 6 of the hollowtube 2, and ultimately exited from the hollow tube 2 30 through thesecond distal end 8 from the lateral openings at the distal end 8 of thehollow tubular member 2 and through the medial openings 68 and/or thelateral openings 69 of the fusion cage 60.

In one embodiment as shown in FIG. 13, the lateral openings at thedistal end 8 of the hollow tubular member 2 are preferably disposedwithin a distance from the distal end 8 not exceeding 25% of the totaldistance (or length) of the hollow tube member 2, more preferably notexceeding 15% of this identified distance, and most preferably notexceeding 10% of this identified distance. In one embodiment as shown inFIG. 13, the lateral openings at the distal end 8 of the hollow tubularmember 2 are preferably disposed within a distance from the distal end 8not exceeding 10 cm of the total distance (or length) of the hollow tubemember 2, more preferably not exceeding 8 cm of this identifieddistance, and most preferably not exceeding 5 cm of this identifieddistance.

Referring to FIGS. 14A-D, sequential elevation views of thesquare-shaped embodiment of the integrated fusion cage and graftdelivery device 1 are provided, depicting sequential elevation views ofthe integrated fusion cage and graft delivery device 1 with the plungerportion 12 fully inserted into the tubular portion 2 and the fusion cage60 fully inserted over the tubular portion 2. One skilled in the artwill appreciate that the openings at the distal end 8 of the hollowtubular member 2 need not be positioned exclusively on one or morelateral sides of the distal end 8 of the tubular member to allow bonegraft material to be provided to the surgical site in other than apurely axial or longitudinal direction. Further, one skilled in the artwill appreciate that the specific absolute and relative geometries andnumbers of lateral and medial openings may vary, for example the distalend 8 of the tubular member 2 may have more than two openings that areof different shape (e.g. oval, rectangular). In one embodiment, thelateral and medial openings 68, 69 of the fusion cage 60 have shapes andsizes that are substantially the same as corresponding openings at thedistal end 8 of the tubular member 2. Further, as generally illustratedin FIGS. 14A-D, when the fusion cage 60 is fully inserted over thetubular portion 2, the openings of the fusion cage 60 and the tubularportion substantially align.

Referring to FIGS. 15A-D, a fusion cage 60 of an integrated fusion cageand graft delivery device portion is shown, which is comprised of anintegrated fusion cage 60 that comprises a first proximal end 62 and asecond distal end 64. The first proximal end contains an opening 66adapted to allow fitting and/or engagement to the distal end 8 of thehollow tube 2. This fitting and/or engagement may be over the externalsurface of the hollow tube 2 or inside the interior of the hollow tube2. Further, the integrated fusion cage 60 may contain non-smoothsurfaces, such as belts or striations, along one or more medial surfaces70 of the integrated fusion cage 60. The integrated fusion cage 60 isconfigured such that when a plunger 12, once fully inserted in to thehollow tube 2, is substantially congruent with the hollow interiorportion of the hollow tube 2, e.g. both the plunger 12 and the hollowtube 2 are substantially the same shape and/or class and bone graftmaterial is delivered through the integrated fusion cage 60 into thesurgical area.

In a preferred embodiment, the fusion cage 60 has a tapered tip, andseveral open channels along the medial and lateral surfaces. In apreferred embodiment, the fusion cage 60 is of a square shape and thebone graft delivery portion of the integrated fusion cage and graftdelivery device is of a cylindrical shape. The integrated fusion cageand graft delivery device 1 is designed to avoid blocking or impactingbone graft material into a surgical disc space, thereby limiting thebone graft material that may be delivered, and not allowing availablefusion space to be fully exploited for fusion.

In a preferred embodiment, the fusion cage 60 has a keel-shaped tip toseparate disk and prevent annular penetration and has internal ramps 72which assist in directing the bone graft material to one or more lateralopenings 69. As the plunger 12 is inserted into the hollow tube 2, bonegraft material is directed by the fusion cage internal ramps 72 out thelateral openings 69, and bone additionally bone graft material may flowout the one or more medial openings 68. The plunger end 18 may beconfigured to be conformal with the internal ramps 72 of the fusion cage60, as depicted in FIG. 15B. Also, the fusion cage 60 may have dualportals for bone graft discharge, with the medial openings 68 largerthan the lateral openings 69. Further, the fusion cage may be designedin variable heights and lengths so that it fits snugly into the prepareddisk space.

In a preferred embodiment as shown in FIGS. 15B-D, the hollow tube 2 isof cylindrical shape and includes one or more locking tabs 80 configuredto engage one or more locking slots 82 of the fusion cage 60. Thelocking tabs 80 may permanently or not permanently engage the lockingslots 82, and may be of shape to include rectangular, circular andoblong. The instruments used with the integrated fusion cage and graftdelivery device described above in its varying embodiments may includeone or more tamps, preferably having a configuration which at least inpart corresponds in shape and contour of the hollow tube portion of thedelivery device. The one or more tamps may be adapted to correspondfurther to the shape and contour of the graspable end of the plunger,for use in driving the plunger through the hollow tube portion of thedelivery device to ensure any remaining bone graft located in the hollowtube is delivered to the graft receiving area.

In the embodiment of the device of FIG. 16, the hollow tube 2 engageswith the fusion cage 60 via a break-off collar 90 and the plunger 12inserts into the interior of the hollow tube 2. The plunger 12 isdepicted partially inserted into the hollow tube 2. The break-off collar90 may be severed by any of several means, to include application oftorsion and/or rotational force and/or lateral force to break-off collar90, for example by twisting on the hollow tube 2 and/or the plunger 12.

In the embodiment of the device of FIG. 17A-B, the hollow tube 2 engageswith a connector conduit 100 which in turn connects with the fusion cage60 via a break-off collar 90. One or more connectors 102 connect thehollow tube 2 with the connector conduit 100. The hollow tube 2 fitsover the connector conduit 100. The one or more connectors 102 fitthrough the hollow tube 2 and the connector conduit 100. The break-offcollar 90 may be severed by any of several means, to include applicationof torsion and/or rotational force and/or lateral force to break-offcollar 90, for example by twisting on the hollow tube 2 and/or theplunger 12. In one embodiment of the connector conduit 100, as shown inFIG. 17B, the connector conduit 100 is of circular cross-section.

Referring to FIGS. 18A-D, sequential elevation views of thesquare-shaped embodiment of the integrated fusion cage and graftdelivery device 1 are provided, depicting sequential elevation views ofthe integrated fusion cage and graft delivery device 1 with telescopingtubular portion 2 and the fusion cage 60 fully inserted over the tubularportion 2. One skilled in the art will appreciate that the openings atthe distal end 8 of the hollow tubular member 2 need not be positionedexclusively on one or more lateral sides of the distal end of thetubular member to allow bone graft material to be provided to thesurgical site in other than a purely axial or longitudinal direction.

In an embodiment of the invention particularly suited for ALIFprocedures, a fusion cage 110 as shown in FIGS. 19A-D comprises a hollowinternal chamber 114 in fluid communication with bone graft dischargeportals 112 and a charging portal 116, which comprises a break-offcollar in some embodiments such as those depicted in FIGS. 17A-D. Thefusion cage 110 has a substantially cylindrical shape, with thedischarge portals 112 located opposite each other on the curved lateralportion of the fusion cage 110 and the charging portal 116 locatedsubstantially in between the discharge portals 112 on the curvedanterior portion of the fusion cage 110. The curved posterior portion ofthe fusion cage 110 is substantially devoid of portals from the internalchamber 114 to the exterior of the fusion cage 110. The charging portal116 is adapted to receive a hollow tube such as the hollow tube 2 shownin other embodiments described herein. Bone graft material enters theinternal chamber 114 through a hollow tube connected to the chargingportal 116, and exits the internal chamber 114 through the dischargeportals 112. The discharge portals 112 are positioned so that when thefusion cage 110 is properly positioned in between two vertebrae, bonegraft material discharged therethrough fills the space in between thevertebrae on the lateral sides of the spine, but does not discharge intoor fill the anterior or posterior space in between the vertebrae. Inembodiments of fusion cage 110 comprising a break-off collar, once thefusion cage 110 is properly positioned and the desired amount of bonegraft material has been inserted into the chamber 114 and dischargedthrough the discharge portals 112, the break-off collar is severed fromthe fusion cage 110 (as described with respect to other embodimentsherein) and removed from the patient's body.

In embodiments that do not comprise a break-off collar, the chargingportal 116 of fusion cage 110 is adapted to removably receive a hollowtube (such as the hollow tube 2 shown in other embodiments describedherein). For example, the walls of the charging portal 116 may bethreaded so that the hollow tube can be screwed into the charging portal116.

The fusion cage 110 preferably has a height of from about 8 millimetersto about 14 millimeters, and a diameter of less than about 36millimeters. The fusion cage 110 is made from polyether ether ketone(PEEK), titanium, a composite material, or any other material suitablefor implantation in a human body. The fusion cage 110 comprises, in someembodiments, ramps within internal chamber 114 to guide bone graftmaterial to discharge portals 112.

In an embodiment of the invention particularly suited for D-LIFprocedures, a fusion cage 120 as shown in FIGS. 20A-D comprises a hollowinternal chamber 124 in fluid communication with bone graft dischargeportals 122 and a charging portal 126, which in someembodiments—including the embodiment shown in FIGS. 20A-D—comprises abreak-off collar. The fusion cage 120 is substantially shaped as arectangular prism, with the discharge portals 122 located on oppositesides of the fusion cage 120 and the charging portal 126 located on alateral face of the fusion cage 120. The opposite lateral face of thefusion cage 120 is devoid of portals from the internal chamber 124 tothe exterior of the fusion cage 120. The charging portal 126 is adaptedto receive a hollow tube such as the hollow tube 2 shown in otherembodiments described herein. Bone graft material enters the chamber 124through a hollow tube connected to the charging portal 126, and exitsthe internal chamber 124 through the discharge portals 122. Thedischarge portals 122 are positioned so that when the fusion cage 120 isproperly positioned in between two vertebrae, bone graft materialdischarged therethrough fills the space in between the vertebrae towardsthe anterior and posterior of the spine, but does not discharge into orfill the lateral space in between the vertebrae. As with otherembodiments described herein, in embodiments that comprise a break-offcollar, once the fusion cage 120 is properly positioned and the desiredamount of bone graft material has been inserted into the chamber 124through charging portal 126 and discharged through the discharge portals122, the break-off collar is severed from the fusion cage 120 (asdescribed with respect to other embodiments herein) and removed from thepatient's body.

In embodiments that do not comprise a break-off collar, the chargingportal 126 is adapted to removably receive a hollow tube (such as thehollow tube 2 shown in other embodiments described herein). For example,the internal walls of charging portal 126 may be threaded so that thehollow tube can be screwed into the charging portal 126.

The fusion cage 120 preferably has a height of from about 8 millimetersto about 14 millimeters, and a length of from about 22 millimeters toabout 36 millimeters. The fusion cage 120 is made from polyether etherketone (PEEK), titanium, a composite material, or any other materialsuitable for implantation in a human body. The fusion cage 120comprises, in some embodiments, ramps within internal chamber 124 toguide bone graft material to discharge portals 122.

Referring now to FIGS. 21A-D, in embodiments of the inventionparticularly suited for use in connection with a vertebrectomy, a fusioncage 130 comprises a substantially cylindrical wall surrounding aninternal chamber 134. Thus, the fusion cage 130 has a substantiallycylindrical shape. Internal chamber 134 is open at the top and thebottom of fusion cage 130, and lateral portions 132 of the cylindricalwall of the fusion cage 130 are porous to bone graft material (i.e. bonegraft slurry). Anterior and posterior portions 138 of the cylindricalwall of fusion cage 130 in between porous portions 132 are impervious tobone graft material. A charging portal 136—which in some embodiments,including the embodiment shown in FIGS. 21A-D, comprises a break-offcollar—is positioned on an impervious portion 138 of fusion cage 130.The charging portal 136 is adapted to receive a hollow tube such as thehollow tube 2 shown in other embodiments described herein. Bone graftmaterial enters the chamber 134 through a hollow tube connected to thecharging portal 136, and exits the chamber 134 through porous wallportions 132. The porous wall portions 132 are positioned so that whenthe fusion cage 130 is properly positioned in between two vertebrae,bone graft material discharged therethrough fills the space in betweenthe vertebrae on either side of the spine, but the impervious wallportions 138 prevent bone graft material from discharging into theanterior or posterior space in between the vertebrae, thus preventingbone graft material from pushing against the spinal cord.

In embodiments of fusion cage 130 comprising a break-off collar, oncethe fusion cage 130 is properly positioned and the desired amount ofbone graft material has been inserted into the chamber 134 throughcharging portal 136 and discharged through the porous wall portions 132,the break-off collar 136 is severed from the fusion cage 130 (asdescribed with respect to other embodiments herein) and removed from thepatient's body. In embodiments that do not comprise a break-off collar,the charging portal 136 is adapted to removably receive a hollow tube(such as the hollow tube 2 shown in other embodiments described herein).For example, the internal walls of the charging portal 136 may bethreaded so that the hollow tube can be screwed into the charging portal136.

The fusion cage 130 preferably has a height equal to or greater than thevertebra or vertebrae it is intended to replace, and a diameter of lessthan about 36 millimeters. The fusion cage 130 is made of polyetherether ketone, titanium, a composite material, or any other materialsuitable for implantation in a human body. In some embodiments, ramps inthe internal chamber 134 guide the bone graft material to the porouslateral faces 132.

Referring now to FIGS. 22-33, another embodiment of the device fordelivering bone graft is provided. In regard to FIGS. 22-28, integratedfusion cage and graft delivery device 1 is shown. FIG. 22 is aperspective view of the device 1, FIG. 23 a perspective exploded view,FIG. 24 a top plan view, FIG. 25 a front elevation view, FIG. 26 a rightelevation view, FIG. 27 is a bottom plan view, and FIG. 28 is across-sectional view of section A-A of FIG. 25.

Device 1 is comprised of a hollow tubular member or hollow tube 2, aplunger 12 which fits within the hollow tube 2, and a funnel 30. Thefunnel 30 engages the upper or proximal or first end 6 of the hollowtube, and comprises a sleeve 32 and opening 34. Medical material, suchas bone graft material, is inserted into opening 34 of funnel 30, whichin turn enters hollow tube 2.

Hollow tube 2 comprises hollow tube first exterior surface 3, hollowtube second exterior surface 5, first end 6, second end 8, and hollowtube first distal opening 7. Hollow tube 2 is generally of symmetricalshape such that first exterior surface 3 comprises two such surfacesopposite or at 180 degrees from one another, and second exterior surface5 comprises two such surfaces opposite or at 180 degrees from oneanother. Also, hollow tube first distal opening 7 is positioned on eachof two opposite sides of hollow tube 2 at second end 8, each openingfrom hollow tube first exterior surface 3.

Funnel 30 is configured with sleeve 32 such that funnel 30 may bepositioned at second end 8 of hollow tube 2 such that hollow tube mayfit through funnel 30, enabling funnel 30 to move along hollow tube 2from second end 8 of hollow tube 2 to first end 6 of hollow tube 2 untilfunnel 30 engages first end 6 of hollow tube, such as at protrusion orshelf depicted in FIG. 23.

Plunger 12 comprises handle 16 at upper or proximal end of plunger 12.Plunger second end 18 comprises distal first surface 13, distal secondsurface 14 and distal third (or bottom) surface 15. Plunger second end18 is generally of symmetrical shape such that distal first surface 13comprises two such surfaces opposite or at 180 degrees from one another,and distal third surface 15 comprises two such surfaces opposite or at180 degrees from one another. Plunger 12 is configured such that secondend 18 forms a congruent or conformal engagement with the interior ofthe hollow tube 2. Stated another way, the plunger second end 18 fitswithin the hollow tube 2 so as to slide within the hollow tube withminimal to no effective spacing between the exterior surface of theplunger second end 18 and the interior of the hollow tube 2, therebyforcing bone graft material positioned in the hollow tube 2 through thehollow tube when the plunger 12 (and thus its second end 18) is axiallymoved from hollow tube first end 6 to hollow tube second end 8.

In regard to FIGS. 29-31, further features of the plunger 12 aredescribed. FIG. 29 is a front elevation view of the plunger element ofthe device shown in FIG. 22, FIG. 30 is a cross-sectional view ofsection B-B of FIG. 29, and FIG. 31 is a cross-sectional of section C-Cof FIG. 29. Plunger 12 comprises handle 16 at upper or proximal end ofplunger 12 and plunger distal or second end 18. Plunger second end 18comprises distal first surface 13, distal second surface 14 and distalthird (or bottom) surface 15. Plunger medial portion 17 forms a crossconfiguration, as depicted in FIG. 30, such that distal first surfaces13 are of reduced width relative to width at second end 18. Similarly,plunger distal second surfaces 14, at plunger medial portion 17, are ofreduced width relative to width at second end 18. At distal end 18 ofplunger 12, plunger cross-section is a rectangle, as depicted in FIG.31.

In regard to FIGS. 32 and 33, additional detail of the distal portion ofdevice 1 are provided. FIG. 32 is a detailed view of a portion of thedevice 1 shown in FIG. 22 and FIG. 33 is a cross-sectional view ofsection D-D of FIG. 32. Each of FIGS. 32 and 33 depict the device 1 whenthe plunger 12 is fully inserted into the hollow tube 2, and the plungerdistal third surface 15 has engaged and is in contact with the hollowtube distal interior ramp 9. Hollow tube distal interior ramp 9comprises hollow tube distal interior ramp surfaces 9A, symmetricallypositioned about the middle of the hollow tube second end 8. Hollow tubedistal interior ramp surfaces 9A are of curvilinear shape forming aterminus, and urge bone graft material, when disposed within the hollowtube 2, to substantially exit the pair of first distal openings 7 of thedevice 1.

Referring now to FIGS. 36-39 another embodiment of an integrated fusioncage and graft delivery device 1 is provided. With reference to FIGS.36-39, the integrated fusion cage and graft delivery device 1 comprisesplunger 12, hollow tube 2, fusion cage 60 and ejection tool 140. Thefusion cage 60 comprises fusion cage second or distal end 64 withtapered end feature and fusion cage first or proximal end 62 comprisingfusion cage collar 92, fusion cage collar face 93 and fusion cage collarcavity 94. Hollow tube 2 comprises hollow tube second end 8 whichengages fusion cage collar 92 by fitting over fusion cage collar 92 in apress or interference fit. Plunger 12 fits within hollow tube 12, andfurther may optionally fit within fusion cage collar cavity 94 so as toenter into interior of fusion cage 60 as previously described above.

Ejection tool 140 comprises ejection tool second or distal end 152 andejection tool first or proximal end 142. Ejection tool second end 152engages fusion cage collar face 93 to apply force or push fusion cage 60from engagement with hollow tube 2. Ejection tool second end 152 isconfigured such that it may not travel past or into the fusion cage.When sufficient axial force is applied to the ejection tool 140 in thedirection of the fusion cage 60, the interference fit that secures thefusion cage 60 (at fusion cage collar 92) to hollow tube 2 (at secondend 8 of hollow tube) is overcome and the fusion cage 60 is released ordisengaged from the hollow tube 2. Ejection tool 140 further comprisesan ejection tool L-cut 151 that engages knobs 6A of hollow tube 2. Inone embodiment, knobs 6A of hollow tube 2 are configured to additionallyor alternatively engage L-cuts of the funnel 30 at funnel sleeve 32 (SeeFIG. 23).

Plunger 12 further comprises handle 16 and plunger stop 16A whichengages upper portion of hollow tube 2. Plunger stop 16A may beconfigured to prevent plunger distal most portion from entering fusioncage collar cavity 94 and therefore further prevent entry into interiorof fusion cage 60.

Fusion cage 60 further comprises fusion cage internal ramps 72 asdescribed above. The fusion cage internal ramps 72 may be symmetricalabout a centerline of the device 1, and may be linear or slopedinwardly. In one embodiment, plunger stop 16A may be configured toprevent plunger distal most portion from striking or contacting fusioncage internal ramps 72 but otherwise allowing entry into fusion cagecollar cavity 94 and therefore also allow entry into interior of fusioncage 60.

Fusion cage 60 further comprises fusion cage first opening or port pair65 and fusion cage second opening or port pair 67. Fusion cage firstopening pair 65 are symmetric about a vertical plane intersecting acenterline of the fusion cage 60, and are located such that at least aportion of the openings are adjacent the tip of the fusion cage internalramps 72. The fusion cage first opening pair 65 are of an oblongracetrack shape, but in other embodiments may be oval, circular andrectangular. The fusion cage second opening pair 67 are of an ovalshape, but in other embodiments may be oblong racetrack, circular andrectangular. The fusion cage may have rounded or no square edges, andmay have a non-smooth exterior surface on any or all portions. That is,the fusion cage 60 may have ridges, bumps, contours, sawtooth profileedges along or on top of any or all exterior surfaces, such as surfacesadjacent the fusion cage second opening pair 67 and/or fusion cage firstopening pair 65.

Referring now to FIGS. 40-41, another embodiment of an integrated fusioncage and graft delivery device 1 is provided. FIG. 40 is a frontperspective view of an integrated fusion cage and graft delivery device1, and FIG. 41 is a closed-up front perspective view of a portion of thedevice of FIG. 40. The embodiment of FIGS. 40-41 comprises a pair offusion cage tab extensions 96, each of which comprises a fusion cage tabextension latch 97. Integrated fusion cage and graft delivery device 1comprises plunger 12, hollow tube 2 and fusion cage 60. FIG. 40 depictsthe integrated fusion cage and graft delivery device 1 with plunger 12fully inserted into hollow tube 2 such that plunger stop 16A engagesupper portion of hollow tube 2. The fusion cage 60 comprises fusion cagesecond or distal end 64 with tapered end feature and fusion cage firstor proximal end 62 comprising fusion cage collar 92, fusion cage collarface 93 and fusion cage collar cavity 94.

Fusion cage 60 further comprises fusion cage internal ramps 72 asdescribed above. The fusion cage internal ramps 72 may be symmetricalabout a centerline of the device 1, and may be linear or slopedinwardly. Fusion cage 60 further comprises fusion cage first opening orport pair 65 and fusion cage second opening or port pair 67. Fusion cagefirst opening pair 65 are symmetric about a vertical plane intersectinga centerline of the fusion cage 60, and are located such that at least aportion of the openings are adjacent the tip of the fusion cage internalramps 72. The fusion cage first opening pair 65 are of an oblongracetrack shape, but in other embodiments may be oval, circular andrectangular. The fusion cage second opening pair 67 are of an ovalshape, but in other embodiments may be oblong racetrack, circular andrectangular. The fusion cage may have rounded or no square edges. Fusioncage 60 has fusion cage surface texture 61, depicted as a series oflateral sawtooth-like ridges.

Fusion cage tab extensions 96, each of which comprises a fusion cage tabextension latch 97, function, among other things, to increase stabilityof the interface or connection between the distal end of the hollow tube2 and the fusion cage 60. The fusion cage tab extension latches 97 maybe configured to engage corresponding grooves on the interior surface ofthe hollow tube 2. The fusion cage tab extensions 96 fit inside the endof the hollow tube and, in one embodiment, provide a force directedoutwards to or against the interior of the hollow tube. The verticalheight and longitudinal (axial) length of the fusion cage tab extensions96 provide more secure fit between the hollow tube 2 and the fusion cage60 by restricting rotational movement, for example, of the hollow tube 2with respect to the fusion cage 60. After bone graft material isprovided to the fusion cage 60 by way of the plunger 12 (as describedabove), the fusion cage tab extensions 96 may be broken-off byapplication of a tool, such as the ejection tool 140, engaged with thefusion cage tab extension latches 97 so as to fatigue or otherwisesevere the fusion cage tab extensions 96.

Referring now to FIGS. 42-43, another embodiment of the ejection tool140 of an integrated fusion cage and graft delivery device 1 isprovided. FIG. 42 is a close-up front perspective view of the ejectiontool first end 142, and FIG. 43 is a cut-away cross-sectional view ofFIG. 42. Ejection tool 140 comprises ejection tool cover 144 whichengages ejection tool wings 149. Ejection tool 140 engages with hollowtube 2 at hollow tube knobs 6A via ejection tool L-cuts 151. Ejectiontool cover 144 comprises cylindrically shaped ejection tool cover cavity145 which fits over cylindrically-shaped ejection tool wings cavity 150and over spring cover 146. Spring cover is secured to ejection toolcover 144 by spring cover attachment 147, which may be a pin, a screw orother means known in the art, and further fits around at least a portionof coiled spring 148. When ejection tool cover 144 is pushed downwardtoward fusion cage 60, the spring 148 compresses and imparts a force inthe opposite direction, thereby returning the ejection tool cover 144 toits original (retracted) position. In use, after securing the ejectiontool first end 142 to hollow tube 2 as described above, the user (e.g.surgeon) squeezes the ejection tool cover 144 against the ejection toolwings 149, thereby advancing the ejection tool rod 160 downwards insidethe hollow tube so as to engage the fusion cage 60 at the fusion cagecollar face 93 and release or disengage the fusion cage 60 from thehollow tube 2. The ejection tool 140 and hollow tube 2 may then beremoved from the surgical site (e.g. spinal disk space) as one unit,leaving the fusion cage in the surgical site.

FIG. 44 is a close-up cut-away cross-sectional view of one embodiment ofthe integrated fusion cage and graft delivery device 1. FIG. 44 depictsa configuration of the integrated fusion cage and graft delivery device1 wherein the plunger 12 is configured to traverse the length of thehollow tube 2, past the fusion cage collar 92 and into the fusion cage60, stopping just prior to engaging the tip of the fusion cage internalramps 72. Fusion cage 60 is depicted with fusion cage first opening pair65 and fusion cage second end 64.

FIGS. 45-48 are scaled drawings of, respectively, the fusion cage 60,the hollow tube 2, the plunger 12 and the ejection tool 140 of yetanother embodiment of the integrated fusion cage and graft deliverydevice 1, and operate in coordination with one another.

FIGS. 45A-G provide scaled views of one embodiment of the fusion cageelement of yet another embodiment of the integrated fusion cage andgraft delivery device configured to operate with the hollow tube ofFIGS. 46A-H, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E.Fusion cage 60 comprises fusion cage second or distal end 64 withtapered end feature and fusion cage first or proximal end 62 comprisingfusion cage collar 92, fusion cage collar face 93 and fusion cage collarcavity 94. Fusion cage 60 further comprises fusion cage first opening orport pair 65, fusion cage second opening or port pair 67, fusion cagesurface texture 61 and fusion cage internal ramps 72.

FIGS. 46A-H provide scaled views of one embodiment of the hollow tube(aka snap on cannula) of the integrated fusion cage and graft deliverydevice configured to operate with the fusion cage element of FIGS.45A-G, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E. Hollowtube 2 comprises first end 6 with knobs 6A and second end 8 comprisinghollow tube cage clamp 8A and hollow tube cage clamp radial surface 8B.Hollow tube cage clamp radial surface 8B is configured to engage fusioncage collar 92, for example by an interference or friction fit (i.e. to“snap-on”). Other means of connection comprise those known to thoseskilled in the art, such as a threaded-screw engagement and a tongue andgroove engagement.

FIGS. 47A-D provide scaled views of one embodiment of the plunger (akasnap on plunger) of the integrated fusion cage and graft delivery deviceconfigured to operate with the fusion cage element of FIGS. 45A-G,hollow tube of FIGS. 46A-H, and ejection tool of FIGS. 48A-E. Plunger 12comprises handle 16, plunger stop 16A, plunger medial portion 17 andsecond end 18. Second end 18 may be configured to pass into and/orthrough fusion cage collar cavity 94.

FIGS. 48A-E provide scaled views of one embodiment of the ejection tool(aka cage insertion tool) of the integrated fusion cage and graftdelivery device configured to operate with the fusion cage element ofFIGS. 45A-G, hollow tube of FIGS. 46A-H and plunger of FIGS. 47A-D.Ejection tool 140 comprises ejection tool second or distal end 152,ejection tool first or proximal end 142 and ejection tool stop 143.Ejection tool second end 152 engages fusion cage collar face 93 to applyforce or push fusion cage 60 from engagement with hollow tube 2.Ejection tool second end 152 is configured such that it may not travelpast or into the fusion cage.

A method of use of the integrated fusion cage and graft delivery device1 as depicted in any of the afore-mentioned embodiments of FIGS. 37-48would be performed as follows. The fusion cage 60 is attached to thehollow tube 2 by way of the above-discussed interference fit at fusioncage collar 92 and interior surface of distal end of hollow tube 2.Funnel 30 is then attached to upper portion of hollow tube at first orupper or proximal end of hollow tube 2 via knobs 6A. Bone graft or othersuitable substance as known to one skilled in the art is inserted atupper or first end 6 of hollow tube 2. Plunger 12 is then inserted intohollow tube 2 at upper or proximal end of hollow tube and pushed oradvanced axially down interior of hollow tube, thereby urging or pushingor advancing the bone graft material down the hollow tube 2 towardfusion cage 60. Bone graft then proceeds into the fusion cage 60 wherebyit at least substantially fills fusion cage 60 interior and furtherengages fusion cage internal ramps 72 and emits bone graft materialthrough fusion cage first opening pair 65 and fusion cage second openingpair 67 and thus enters surgical area (e.g. a spinal surgical area).Upon sufficient user (i.e. surgeon) selectable injection of bone graftmaterial into surgical site and fusion cage 60, the plunger 12 isretracted and removed from the hollow tube 2 by opposite axial movement,i.e. by moving the plunger 12 away from the fusion cage 60. The funnel30 may then be optionally removed.

Next, the ejection tool 140 is inserted into hollow tube 2 at upper orproximal end Ejection tool 140 is advanced until ejection tool secondend 152 engages fusion cage collar face 93, whereupon downward force isapplied to push fusion cage 60 from engagement with hollow tube 2. Asdiscussed, ejection tool second end 152 is configured such that it maynot travel past or into the fusion cage. When sufficient axial force isapplied to the ejection tool 140 in the direction of the fusion cage 60,the interference fit that secures the fusion cage 60 (at fusion cagecollar 92) to hollow tube 2 (at second end 8 of hollow tube) is overcomeand the fusion cage 60 is released or disengaged from the hollow tube 2.The engagement tool 140, and the hollow tube 2 in which it is inserted,are then removed from the surgical site, leaving a fusion cage at leastsubstantially filled with bone graft and a surgical site also at leastsubstantially filled with bone graft.

In one embodiment, all or a portion of fusion cage collar 92 is of amaterial different than the remainder of the fusion cage 60, e.g.comprising a metal alloy. In one embodiment, a portion of the distal endof the hollow tube 2 is of a material different than the remainder ofthe hollow tube 2, e.g. comprising a metal alloy. In one embodiment, aportion of the distal end of the ejection tool is comprised of a metalalloy.

In one embodiment of the device, the tip of the hollow tube and/orfusion cage may separate under a threshold pressure as applied axiallyfrom the inside of the hollow tube or fusion cage respectively. Such auser-selected threshold would allow bone graft material to enter thesurgical site if bone graft material becomes clogged in the hollow tubeand/or fusion cage.

Referring now to FIGS. 49-62, various embodiments and components of afusion cage 60 with expandable fusion cage feature are depicted.Generally, the fusion cage 60 comprises an upper plate 200, lower plate210, front block 220, rear block 230, and expansion screw 240. Byrotating the expansion screw 240, each of the front block 220 and rearblock 230 advance toward the center of the fusion cage 60 whilesimultaneously advancing each of the lower plate 210 and upper plate 220away from the center of the fusion cage 60, thereby expanding theoverall height of the fusion cage 60. Each of the unexpanded state ofthe fusion cage 60 and expanded state of the fusion cage 60 areunderstood most immediately by comparing FIGS. 49A and 50A,respectively. The fusion cage 60 may be expanded in a scalable manner toa maximum threshold height value. At the maximum threshold height valueof the fusion cage 60, each of the front block 220 and rear block 230are unable to continue to advance toward the center of the fusion cage60 (such a state is shown as FIG. 50A). It is noted that in theembodiments of FIGS. 49-60, the lower plate 210 and upper plate 220remain substantially parallel in all configurations. Stated another way,the lower plate 210 and upper plate 220 remain substantially parallel inthe unexpanded fusion cage 60 state (e.g. FIG. 49A), in the maximumthreshold height value expanded state of the fusion cage 60 (e.g. FIG.50A), and in all states in between. In contrast, in the fusion cage 60embodiment of FIGS. 61A-B, the lower plate 210 and upper plate 220maintain a relative vertical wedge angle α, and in the embodiment ofFIGS. 62A-B, the lower plate 210 and upper plate 220 maintain a relativehorizontal wedge angle β.

Expansion screw 240 comprises expansion screw head 242, expansion screwtip 244 and expansion screw disk 246. The expansion screw 240rotationally engages each of the front block 220 via front blockaperture 227 and rear block 230 via rear block aperture 237. Theexpansion screw disk 246 engages each of the upper plate 200 via upperplate slot 206 and the lower plate 210 via lower plate slot 216. Theexpansion screw 240 is configured with opposing screw threads on eachside of expansion screw disk 246. Each of the front block aperture 227and rear block aperture 237 are tapped to accept the expansion screw 240threads. As such, as the expansion screw 240 is rotated, each of theopposing screw threads engage each of the front block aperture 227 andrear block aperture 237 and advance the respective front block 220 andrear block 230 toward the center of the fusion cage 60. As provided inFIGS. 57A-C, expansion screw 240 comprises left hand threads on a firstportion of expansion screw 240 proximal to the expansion screw head 242and right hand threads on a second portion of expansion screw 240 distalto the expansion screw head 242. Thus, the left hand threads engage therear block aperture 237 and the right hand threads engage the frontblock aperture 227. The left hand and right hand threads are symmetricalalthough in opposite directions such that rotation of the expansionscrew 240 results in equal movement of each of the front block 220 andrear block 230. Stated another way, the operation of the expansion screw240 with respect to the front block 220 and rear block 230 is such thateach block advances toward (or retreats from) the center of the fusioncage 60 in equal amounts or distance with rotation of the expansionscrew 240.

In an alternate embodiment, the thread configurations (and respectivetapped apertures) are reversed. The expansion screw head 242 is fittedwith a star terminus so as to engage a star (a.k.a. Torx™) screwdriver.In other embodiments, the expansion screw head 242 is fitted with a starscrewhead (i.e. female, i.e. receptor, end) so as to engage a starscrewdriver (i.e. a male screwdriver.). In other embodiments, any meansof screw drive known to those skilled in the art may be employed, toinclude slot or regular, phillips, pozidriv, square, Robertson, hex, hexsocket, tri-wing, spanner head, clutch, double-square, triple-square,polydrive, spline drive, double hex, Bristol and pentalobular.

Front block 220 comprises front block upper rail 222, front block lowerrail 224, front block nose 225, front block ramp 226 and front blockaperture 227. As described above, front block aperture 227 is tapped toengage the threads of expansion screw 240. Each of front block upperrail 222 and front block lower rail 224 engage, respectively, upperplate track 205 and lower plate track 215. Such a configuration orarrangement may be referred to as a dovetail joint slider. As theexpansion screw is rotated, front block upper rail 222 moves or slideswithin upper plate track 205 toward the center of fusion cage and frontblock lower rail 224 moves or slides within lower plate track 215 towardthe fusion cage. Because of the wedged-shaped geometry of each of thefront block 220 and rear block 230, such movement toward the center ofthe fusion cage 60 results in an expansion (in height) of the fusioncage 60. Such movement also causes a reduction in the length of thefusion cage 60, in that the front block nose 225 retreats to theinterior of the fusion cage 60, thereby leaving the upper plate front201 and lower plate front 211, or the expansion screw tip 244, to definethe most distal end of the fusion cage 60. Such a change in fusion cage60 length is apparent by comparing, for example, FIGS. 49A and 50A. Inone embodiment, the expansion screw tip 244 is configured such that,when the fusion cage 60 is in a maximum expansion state, the expansionscrew tip 244 does not extend beyond a plane between the most distal endof the upper plate front 210 and lower plate front 211. It is noted thatin all states of expansion of the fusion cage 60, no aperture is formedat the nose of the fusion cage 60, e.g. between the front block 220 andeach of the upper plate 200 and lower plate 210. Stated another way, inall states of expansion of the fusion cage 60, to span unextended state(e.g. FIG. 49a ) and maximum extended state (e.g. FIG. 50A), no path foregress of material (e.g. bone graft) is provided from the interior ofthe fusion cage 60 through the front or nose area (i.e. in alongitudinal direction.) In an alternate embodiment, the front block 220is configured with one or more apertures, e.g. on one or more of frontblock ramp 236, so as to allow a path for the egress.

Front block 220 is symmetrical about a vertical plane (i.e. a planerunning parallel to each of front block upper rail 222 edge and frontblock lower rail 224 edge longitudinal axes and bisecting front blockaperture 227 at 12 and 6 o'clock positions.) Front block is symmetricalabout a horizontal plane (i.e. a plane running parallel to each of frontblock upper rail 222 surface and front block lower rail 224 surface andbisecting front block aperture 227 at 3 and 9 o'clock positions.)

Rear block 230 comprises rear block groove 231, rear block upper rail232, rear block lower rail 234, rear block ramp 236, rear block aperture237, rear block aft 238 and rear block detent 239. As described above,rear block aperture 237 is tapped to engage the threads of expansionscrew 240. Each of rear block upper rail 232 and rear block lower rail234 engage, respectively, upper plate track 205 and lower plate track215. As the expansion screw is rotated, rear block upper rail 232 movesor slides within upper plate track 205 toward the center of fusion cageand rear block lower rail 234 moves or slides within lower plate track215 toward the fusion cage. Because of the wedged-shaped geometry ofeach of the rear block 230 and rear block 230, such movement toward thecenter of the fusion cage 60 results in an expansion (in height) of thefusion cage 60. The rear block aft 238 is configured such that when thefusion cage 60 is in an unexpended state (e.g. FIG. 49A), the rear blockaft 238 is flush with the edges of each of upper plate rear 202 andlower plate rear 212. In one embodiment, the expansion screw head 242 isconfigured such that, when the fusion cage 60 is in an unexpanded state,the expansion screw head 242 is flush with the edges of each of upperplate rear 202, lower plate rear 212 and rear block aft 238.

Rear block 230 is similarly symmetrical about the same relative axes asfront block 220. That is, rear block 230 is symmetrical about a verticalplane (i.e. a plane running parallel to each of rear block upper rail232 edge and rear block lower rail 234 edge longitudinal axes andbisecting rear block aperture 237 at 12 and 6 o'clock positions.) Rearblock is symmetrical about a horizontal plane (i.e. a plane runningparallel to each of rear block upper rail 232 surface and rear blocklower rail 234 surface and bisecting front block aperture 237 at 3 and 9o'clock positions.)

Upper plate 200 comprises upper plate front 201, upper plate rear 202,upper plate opening 203, upper plate surface texture 204, upper platetrack 205, upper plate slot 206, upper plate ridge 209 and plate tab217. Upper plate surface texture 204 is formed of consecutive ridges ina lateral orientation, i.e. left-right rather than fore-aft. Inalternate embodiments, the upper plate surface texture 204 is formed ina longitudinal direction, i.e. fore-aft rather than left-right. In otheralternate embodiments, the upper plate surface texture 204 is of otherconfigurations known to those skilled in the art, to comprise groovesand ridges. Upper plate opening 203 comprises a pair of oval race-trackopenings. In other embodiments, upper plate opening 203 is a singleopening, is of circular shape, is of rectangular shape, or other shapesknown to those skilled in the art and/or conventionally used in fusioncages. Upper plate 200 is symmetric about a vertical plane runninglongitudinally between the two upper plate openings 203 and the upperplate track 205.

Lower plate 210 comprises lower plate front 211, lower plate rear 212,lower plate opening 213, lower plate surface texture 214, lower platetrack 215, lower plate slot 216, lower plate ridge 219 and plate tab217. Lower plate surface texture 214 is formed of consecutive ridges ina lateral orientation, i.e. left-right rather than fore-aft. Inalternate embodiments, the lower plate surface texture 214 is formed ina longitudinal direction, i.e. fore-aft rather than left-right. In otheralternate embodiments, the lower plate surface texture 214 is of otherconfigurations known to those skilled in the art, to comprise groovesand ridges. Lower plate opening 213 comprises a pair of oval race-trackopenings. In other embodiments, lower plate opening 213 is a singleopening, is of circular shape, is of rectangular shape, or other shapesknown to those skilled in the art and/or conventionally used in fusioncages. Lower plate 210 is symmetric about a vertical plane runninglongitudinally between the two lower plate openings 213 and the lowerplate track 215.

When the fusion cage 60 is in the unexpanded state (e.g. FIG. 49A),upper plate ridge 209 and lower plate ridge 219 are in communication,i.e. are touching or substantially touching.

Upper plate 200 and lower plate 210 are identical, and are assembled toform the fusion cage 60 by positioning in opposite orientations. Statedanother way, upper plate 200 and lower plate 210 are positioned tomirror one another about a horizontal plane through the center andmiddle height of the fusion cage 60. Among other things, identical upperplate 200 and lower plate 210 allow fewer unique parts to be used toassemble the fusion cage 60, thereby reducing costs, reducingcomplexity, and increasing robustness. Also, the fusion cage 60 designis such that the fusion cage remains structural stable and strong whileexpanded, to include when in the maximum expanded state, as enabled bythe type and degree of connections between the wedged blocks and theplates. That is, as enabled by the rail/track connections between theblocks and the plates, and also the adjacent surface connections of thewedged blocks (i.e. the area adjacent the rails of each block) and theplates.

The fusion cage 60 is a modular system in that components may becombined to cover several sizes and configurations. Although each of theupper plate 200 and lower plate 210 are identical, these paired platesmay be provided in several sizes. For example, as provided in FIGS.54A-F, a set of paired (i.e. one upper plate 200 and one lower plate210) plates may be provided in lengths of 26 mm, 32 mm and 36 mm. Also,the paired wedged blocks (i.e. a front block 220 and a rear block 230)may be provided in assorted sizes, e.g. an 8 mm and an 11 mm size, asdepicted in FIGS. 55A-E. Lastly, the expansion screw 240 may be providedin various configurations, as provided in FIGS. 57A-C, to matchcombinations of paired plates and paired wedged blocks. In oneembodiment, the fusion cage 60 may be constructed to range in size from8×26 mm to 14×36 mm.

In one embodiment, the expansion screw 240 comprises stainless steel andtitanium, and the upper plate 200 and lower plate 210 comprise stainlesssteel, titanium and polyether ether ketone (PEEK.)

Additional components that are configured to engage the fusion cage 60are provided in FIGS. 63-72. Generally, the additional componentscomprise those that allow the fusion cage 60 to be positioned at orwithin a surgical site, to expand and/or contract the fusion cage 60,deliver bone graft material within the fusion cage 60 and to thesurrounding surgical site, and detach the fusion cage.

With attention to FIGS. 63-69, a fusion cage 60 with expandable fusioncage feature, as described above, is depicted with an installer/impactor250 component. The installer/impactor 250 comprises installer/impactortip 252, installer/impactor aperture 253, installer/impactor ridge 254,installer/impactor channel 255, installer/impactor ramp 256 andinstaller/impactor handle 258. The installer/impactor aperture 253 isconfigured to engage the rear block aperture 253 and theinstaller/impactor ridges 254 are configured to engage the rear blockdetent 239; once these elements are engaged, the fusion cage 60 may beaccurately and reliable positioned at the surgical site. Theinstaller/impactor handle 258, with integrated striking plate, may beused to assist in guiding the fusion cage 60 into place, and furtherallows a “persuading” with a mallet. The installer/impactor handle 258attaches in place with, for example, a ball detent or similar featurethat secures the installer/impactor handle 250 in place yet allows quickand easy removal.

FIG. 65A details the installer/impactor 250 engaged with the fusion cage60, the fusion cage 60 in an unexpanded state. FIG. 65B details the samesystem and configuration of FIG. 65A, except that the expansion driver260, with expansion driver handle 268, is engaged with the fusion cage60. More specifically, the expansion driver 260, which fits within theinstaller/impactor 250, engages the expansion screw head 242 (e.g. theexpansion screw head 242 is a male star or Torx™ screw head that engageswith the female star or Torx™ screwdriver end of the expansion driver260.) FIG. 66 details the installer/impactor 250 engaged with the fusioncage 60, the fusion cage 60 in an expanded state (as a result of theexpansion driver 260 engaging the expansion screw head 242 and, throughrotation of the expansion screw head 242, expanding the fusion cage 60),and the hollow tube 2 fitted over the installer/impactor 250.

After the fusion cage 60 is expanded to the desired degree, i.e. height,the expansion driver 260 disengages from the expansion screw head 242and is removed. The hollow tube 2 is then slid downward or distally soas to engage the fusion cage 60, and the installer/impactor 250 must beremoved (so as to allow bone graft material to be delivered via hollowtube 2 into the fusion cage 60 and the surrounding surgical site.) FIG.67 details the installer/impactor 250 engaged with the fusion cage 60,the fusion cage 60 in an expanded state, and the hollow tube 2 fittedover the installer/impactor 250 and engaged with the fusion cage 60;this is the configuration of the integrated expandable fusion cage andbone graft delivery device when the installer/impactor 250 must beremoved so as to enable bone graft delivery. In an alternate embodiment,the installer/impactor 250 is not used, and instead the hollow tube 2 isused to position the fusion cage 60 by way of the hollow tube externalramp 280 and/or hollow tube notch 282. The hollow tube external ramp 280may form a press-fit with the fusion cage 60. The hollow tube may alsoengage the fusion cage 60 via the hollow tube notch 282, the hollow tubenotch 282 configured to engage the rear block aft 238 portion above andbelow the rear block aperture 237.

FIGS. 68A-B detail a means with which the installer/impactor 250 may beremoved by use of removal pliers 270. The removal pliers 270 areconfigured to engage the first end 6 of hollow tube and the proximal endof the installer/impactor 250, so as to pull the installer/impactor 250from engagement with the fusion cage 60. Note that theinstaller/impactor 250 is configured to allow the installer/impactor tip252 to spread apart over the rear block detent 239 groove, asfacilitated by the installer/impactor channel 255.

After the fusion cage 60 has been positioned in the surgical site andexpanded as required, bone graft material may be inserted into thefusion cage 60 and into the surrounding surgical site. FIG. 69 presentsan exploded perspective view of the fusion cage 60 with expandablefusion cage feature engaged with the hollow tube 2 component and funnel30 component, as configured to engage with the plunger 12 component. Asdescribed previously, bone graft material is placed into the funnel 30and advanced down the hollow tube 2 by the plunger 12, whereby bonegraft material flows into the fusion cage 60 and outward into thesurgical site via one or more of the upper plate openings 203, lowerplate openings 213, and lateral openings distal to the front block 230.

FIGS. 70-72 depict an alternate embodiment of hollow tube 2 and fusioncage 60 to enable the fusion cage 60 to be accurately and reliablypositioned at a surgical site. The hollow tube 2 comprises two pairs ofhollow tube slots 284, each with a hollow tube slot aperture 285 at thedistal end. Each hollow tube slot 284 is disposed at least partially onthe hollow tube external ramp 280. Each of the upper plate 200 and lowerplate 210 comprise a pair of plate tabs 217, each of which engages oneof the hollow tube slot apertures 285. When such an engagement occurs,the fusion cage 60 is slightly expanded as the hollow tube 2 is insertedinto the fusion cage 60. In this arrangement, as the fusion cage 60 isexpanded, the plate tabs 217 retreat or release from the hollow tubeslot apertures 285; however, the hollow tube 2 still engages orregisters with the fusion cage 60 via the hollow tube notches 282 whichremain engaged with the rear block aft 238.

In one embodiment, the expansion screw 240 is configured to lock atdefined expansion states of the fusion cage 60, to include at a maximumexpansion state (as defined, e.g. as the maximum height dimension ofwhich the fusion cage 60 may expand.)

In another embodiment, the fusion cage 60 with expandable cage featureis configured of modified and integrated embodiments of theafore-mentioned components. For example, FIG. 73 depicts a fusion cage60 with expandable fusion cage feature wherein the upper plate 200 andlower plate 210 are joined through a plate nose element 218 (“plate/noseelement”). These combined components are configured to form a firststate wherein a minimal vertical height is provided and/or a flatprofile is presented. Horizontal notches fitted between the upper plate200 and plate nose element 218, and between the lower plate element 210and plate nose element 218, enable the integrated upper plate 200, lowerplate 210 and plate nose element to expand upon engagement with anintegrated front block 220 and rear block 230 element.

The integrated front block 220 and rear block 230 element comprises ablock spine 228 (“block/spine element”) such that, when inserted intothe afore-mentioned plate/nose element, the fusion cage 60 expands. Inone embodiment, each of the afore-mentioned integrated components wouldbe held in a pistol grip type insertion tool (as known to those skilledin the art) which would allow placement of the unexpanded (i.e. thecollapsed) plate/nose element into the surgical site (e.g. a disk space)with the block/spine element staged right behind. Upon pulling a leveron the pistol grip tool, the plate/nose element would be inserted intothe block/spine element (in one embodiment, this insertion isfacilitated by upper plate track 205 and lower plate track 215 engagingrespective upper and lower rails of the block/spine element), therebyexpanding the plate/nose element and forming an expanded fusion cage 60.In one embodiment, a locking feature is provided such that theplate/nose and block/spine elements are secured or locked together. Inone embodiment, the insertion of this fusion cage 60 embodiment is byway of hollow tube 2 (e.g. the embodiment described in FIGS. 70-72). Inone embodiment of the fusion cage 60 as provided in FIG. 73, one or moreupper plate openings 203 and/or one or more lower plate openings 213 areprovided.

In one embodiment, no springs, such as wire springs, are employed toexpand the fusion cage 60. In one embodiment, other means, as known tothose skilled in the art, are used to expand the fusion cage 60, toinclude springs, gears, cams, magnetic, electrical, electromechanical,electro-magnetic, and optical.

The means and components disclosed may engage, integrate and/orcommunicate with the fusion cage 60 embodiments of the disclosure aswell as with traditional and conventional fusion cages. That is, thecomponents of the disclosure may be readily adapted to engageconventional fusion cages, including expandable fusion cages, of theprior art. More specifically, the hollow tube 2, installer/impactor 250,expansion driver 260, and/or plunger 12 may be adapted to engage fusioncages of the prior art. FIG. 74 provides a representative depiction ofadaptations of components of the disclosure so as to engage conventionalfusion cages, both fixed or static fusion cages and expandable fusioncages.

In one embodiment, the bone graft delivery system of the disclosure mayengage with an expandable fusion cage of the prior art. For example, thehollow tube 2 may be configured to engage the prior art (expandable)fusion cage 400 shown by, for example, geometric sizing of the hollowtube first distal opening 8, and/or fitting the hollow tube first distalopening 8 with a malleable portion that may be compressed and/orexpanded so as to engage the prior art (expandable) fusion cage 400,and/or fitting to an adaptor 300 portion. Additionally, theinstaller/impactor 250 may be adapted (e.g. to use the sameconfiguration of expansion end as that of the depicted fusion cage) tocommunicate with the end portion of the prior art (expandable) fusioncage 400 so as to enable the expansion of the prior art (expandable)fusion cage 400. The prior art (expandable) fusion cage 400 may also beengaged with one or more components of the disclosure, e.g. the hollowtube 2 and/or installer/impactor 250.

In one embodiment of the fusion cage 60, the fusion cage of the priorart is adapted wherein one or more of the upper plate 200 and/or lowerplate 210 is adapted to fit on paired opposite sides of the fusion cage.

In another embodiment, the bone graft delivery system of the disclosuremay engage with an unexpandable fusion cage of the prior art. The hollowtube 2 is configured to engage the prior art (unexpandable) fusion cage400 shown by, for example, geometric sizing of the hollow tube firstdistal opening 8, and/or fitting the hollow tube first distal opening 8with a malleable portion that may be compressed and/or expanded so as toengage the prior art (expandable) fusion cage 400, and/or fitting to anadaptor portion 300.

FIG. 74 depicts the bone graft delivery system of the disclosure, asengaged with an unexpandable fusion cage of the prior art, specificallyan unexpandable fusion cage provided in US2012/0065613 and/orhttp://thompsonmis.com/node/23, incorporated herein by reference inentirety. The hollow tube 2 is configured to engage the prior art(unexpandable) fusion cage 400 shown by, for example, geometric sizingof the hollow tube first distal opening 8, and/or fitting the hollowtube first distal opening 8 with a malleable portion that may becompressed and/or expanded so as to engage the prior art (expandable)fusion cage 400, and/or fitting to an adaptor portion 300 (as shown).

In one embodiment, the adaptor 300 comprises at least two forked tinesto engage, for example, exterior surfaces of a fusion cage. In oneembodiment, the adaptor 300 forms an angled tool, that is, the adaptor300 and the hollow tube 2 are not aligned or linear. In anotherembodiment, the adaptor 300 forms an angled tool relative to a fusioncage when engaged with a fusion cage, that is, the adaptor 300 and thehollow tube 2 are aligned or linear but are not in alignment with anengaged fusion cage.

In one embodiment, the fusion cage 60 is actuated, e.g. the expansionscrew 240 is operated, remotely, e.g. through electrical means, magneticmeans or other means known to those skilled in the art, during surgeryor post-operative. The later situation, i.e. post-operative, enablesadjustment of the height of the fusion cage 60 after surgery. In oneembodiment, the fusion cage (e.g. the expansion screw) is operated ormanipulated by way of additional devices to comprise a servo-motor.

In one embodiment, the fusion cage 60 is used in applications comprisingL-LIF, ALIF, Corpectomy adaptation, deformity correction and increasinglordosis.

In one embodiment, the expansion screw 240, comprising a left-hand and aright-hand threaded screw portion and a central disk, engages twoopposing blocks at a 30-degree ramp angle with a dovetail joint. As theblocks are drawn in, the cage plates are forced outward (in the verticaldirection). The narrow disk at the center of the screw registers in theslots of the cage plates to keep the plates from shifting fore/aft,reducing if not eliminating binding of the mechanism.

In one embodiment, at least some of the fusion cage is manufacturedusing 3-D printing technologies, metal additive manufacturing (AM),subtractive machining and/or direct metal laser sintering (DMLS) and maybe provided a porous coating. In one embodiment, the fusion cage 60comprises one or more surfaces, especially exterior surfaces, with poresso as to, for example, promote osseointegration. The article “EOS Teamswith Medical Implant Designer to Advance 3D Printing in Medicine”published Oct. 17, 2012 in Graphic Speak is incorporated by reference inentirety.

In one configuration, the fusion cage of the present disclosurecomprises a titanium alloy, such as Ti6AL4V and/or lattice structures,the lattice structures covering all or at least part of one or moreapertures of the fusion cage 60.

In one configuration, the hollow tube 2 is configured such that itsdistal upper and lower interior surfaces have grooves to engage theupper and lower portions of the rear cage actuating wedge. The screwtool, fitting inside the cannula, is still used to expand the cage. Onceexpanded, the screw tool is removed. Then BG material is inserted usingthe cannula/plunger scheme. Furthermore, the distal end of the modifiedcannula may be made of an elastic material so that, if initially engagedwith the cage in compression, it expands as the cage expands to providea sealed fit with the cage as the cage expands, thereby allowing a cleanflow of BG material into the cage i.e. no back-flow.

In one embodiment, one or more alignment markers are placed on thefunnel, e.g. lines at 0 degree and 180 degree. In one embodiment, one ormore clamps are applied to the hollow tube for additional support and/orstability. The clamps may be, e.g. scissor-type clamps. In oneembodiment, all or a portion of the plunger, hollow tube, fusion cageand ejection tool comprise a thermoplastic polycarbonate such as Lexan™.In one embodiment, the fusion cage comprises a different material thanone or more of the hollow tube, plunger and ejection device. In oneembodiment, the plunger comprises an elastic portion and elastic sealwhich functions, among other things, to restrict wiggle of the plungerwhen moving through the hollow tube. In one embodiment, one or moreportions of the device are manufactured via sonic welding, and/orcomprise a sonic weld. For example, the tip of the hollow tube and/orfusion cage may be sonic welded or comprise a sonic weld.

Referring now to FIGS. 75A-75E, an embodiment of an integrated fusioncage and graft delivery device 1 of the present disclosure isillustrated. The graft delivery device generally includes a cannular orhollow tube 2, a plunger 12, and a detachable funnel 30.

The hollow tube 2 is the same as, or similar to, other embodiments ofhollow tubes described herein. Accordingly, the hollow tube 2 generallyincludes an opening 4 at a proximal end 6. At least one dischargeopening 7 is associated with a distal end 8 of the hollow tube. In oneembodiment, the discharge opening 7 is positioned transverse to alongitudinal axis of the hollow tube 2. Accordingly, in one embodiment,the distal end 8 is at least partially closed opposite to the proximalopening 4. Alternatively, the distal end 8 may be completely closed.Optionally, a discharge opening 7 may be formed through at least aportion of the distal end. Specifically, in one embodiment, the hollowtube 2 can include a discharge opening 7 aligned with a longitudinalaxis of the hollow tube.

In one embodiment, the distal end 8 is rounded or smooth with awedge-shape 50. Specifically, the distal end can have a shape configuredto facilitate easy entry into a disc space. In this manner, the shape ofthe distal end minimizes soft tissue damage or irritation. Thewedge-shape 50 enables insertion of the distal end 8 into a collapseddisc space without damaging the endplates or skating off to anunintended location. In contrast, some prior art devices with an opendistal end can injure bony end plates of the disc space of a patient.

Optionally, the hollow tube includes two discharge openings 7A, 7B. Thetwo discharge openings 7 can be arranged on opposite sides of the hollowtube to eject graft material. Accordingly, in one embodiment, the hollowtube 2 is operable to dispense bone graft material laterally away from alongitudinal axis of the graft delivery device 1. In one embodiment, thetwo discharge openings 7 are of substantially the same size and shape.The discharge openings 7 may have a generally oval shape.

In another embodiment, at least one opening 7C (illustrated in FIG. 75D)is formed in the distal end 8. Thus, the graft delivery device 1 maydischarge bone graft material through the distal end 8 in line with thelongitudinal axis of the graft delivery device 1. The opening 7C mayhave any predetermined shape. Optionally, the opening 7C has arectangular, round, or ovoid shape. The distal end 8 may optionallyinclude a taper or wedge shape 50 with an end opening 7C formedtherethrough.

The hollow tube 2 is substantial hollow between the proximal end and thedistal end. Specifically, a lumen 28 extends through the hollow tube 2.The lumen 28 has a predetermined cross-sectional shape. In oneembodiment, the cross-sectional shape of the lumen is one of round,ovoid, square, and rectangular. In another embodiment, the interior ofthe lumen is not round and is, for example, rectangular. Optionally, thecross-sectional shape of the lumen 28 is substantially uniform along thelength of the hollow tube 2. In one embodiment, the lumen 28 has auniform cross-sectional size along its length. The exterior of thehollow tube 2 may have a shape that is one of round, ovoid, square, andrectangular.

A ramp 9 may be formed within the hollow tube proximate to the opening7. As described herein, the ramp 9 includes surfaces configured todirect the bone graft material away from the opening 7 into a surgicalsite, such as a disc space. More specifically, the ramp 9 functions as areverse funnel to disperse bone graft material ejected from the opening7 as generally illustrated in FIG. 76A.

In one embodiment, surfaces of the ramp 9 are linear in shape, that is,forming a triangle in cross-section. In another configuration, surfacesof the ramp 9 are of any shape that urges egress of bone graft materialcontained in the hollow tube to exit the lumen 28 of the hollow tube 2through the at least one opening 7 of the device 1.

The hollow tube 2 is configured to receive the plunger 12 of the presentdisclosure within the lumen 28. Any plunger 12 of the present disclosuremay be used with the hollow tube 2. The plunger 12 can be used to pushbone graft material positioned in the lumen 28 out of the opening 7 atthe distal end 8. Optionally, a stop 16A can be formed on the plunger 12to engage the proximal end 6 of the hollow tube. In this manner, thestop 16A prevents over insertion of the plunger within the lumen.

Optionally, the plunger 12 may include a plurality of teeth separated bynotches 27. The notches 27 can be engaged by a means for advancing bonegraft material described herein.

In one embodiment, the means for advancing comprises a ratchetconfigured to engage the notches 27. In operation, the ratchet canengage successive notches to advance or withdraw the plunger within thehollow tube.

Additionally, or alternatively, the means for advancing can include agear with teeth. The gear is aligned with the plunger and operable toconvert rotational movement of the rear to linear movement of theplunger. As the gear rotates, the gear teeth engage the plunger notches27 to move the plunger toward or away from the hollow tube distal end.

In still another embodiment, the means for advancing comprises a wormgear with at least one helical thread. As the worm gear rotates, thehelical thread engages the plunger notches 27. In this manner, the wormgear can advance or retract the plunger within the hollow tube.

The plunger 12 includes a distal end 18. The distal end 18 substantiallyconforms to inner walls of the lumen 28. Specifically, in oneembodiment, the distal end 18 has a cross-sectional shape whichcorresponds to the interior shape of the lumen 28. Optionally, theplunger distal end 18 is round, ovoid, square, or rectangular. In oneembodiment, the distal end 18 is not round. In another embodiment, theplunger distal end is configured to contact the inner walls of the lumen28 about an entire outer periphery of the plunger distal end.Additionally, or alternatively, the plunger 12 (or a portion of theplunger 12) may be made of rubber silicone to improve the seal withinterior surfaces of the lumen 28. In some embodiments, at least thedistal end 18 is made of a plastic or an elastomeric rubber.

In one embodiment, the plunger has a length sufficient for the distalend 18 of the plunger to extend beyond the opening 7 as generallyillustrated in FIG. 75C. In one embodiment, the handle 16 of plunger isa planar disk shape, as depicted in FIG. 75C. In another embodiment,handle 16 is not planar. For example, handle 16 is angled so as toconform to interior of funnel 30 when the plunger 12 is fully insertedinto hollow tube 2.

Notably at least one vent port 21 may be formed through the hollow tube2 to the lumen 28. The vent port 21 is configured to release air fromthe interior of the hollow tube 2 as bone graft material is delivered tothe distal end 8 for discharge out of the opening 7. As one of skill inthe art will appreciate, air trapped within the lumen 28 of the hollowtube 2 between the distal end 8 and bone graft material may increase theamount of axial force required by the plunger 12 to move the bone graftmaterial to the discharge opening 7 or may cause the plunger to jam orbind in the lumen. Applying excessive force to the plunger to eject thebone graft material can cause soft tissue inflammation or damage. Byallowing air to escape from within the lumen 28 of the hollow tube 2 asthe plunger 12 is pressed toward the distal end 8, the vent port 21 maydecrease the amount of force required to deliver the bone graft materialto the discharge opening 7. The possibility of the plunger 12 jammingwithin the hollow tube 2 is also reduced. Specifically, the vent port 21eliminates or reduces the risk of jamming the plunger and also reducesthe possibility of trapped air being forced into the disc space and intothe patient's vascular system causing an air embolism.

The vent ports 21 also prevent introduction of air or other fluids intothe surgical site. For example, air may be introduced into, and trappedwithin, bone graft material as the bone graft material is loaded intothe hollow tube. As the plunger presses against the bone graft material,the air may be released from the bone graft material. The air can escapefrom the lumen 28 through the vent ports 21.

Vent ports 21 can be formed through the hollow tubes 2 of allembodiments of the present disclosure. Vent ports 21 may be formed atany location of the hollow tube 2 along the length of the hollow tubebetween to proximal end 6 and the distal end 8. Optionally, a vent port21 is formed on at least one of the first surface 3 and the secondsurface 5. In one embodiment, vent ports 21 can be formed on more thanone surface 3, 5 of the hollow tube.

The at least one vent port 21 is configured to prevent discharge of bonegraft material from the lumen 28. Accordingly, the vent port 21 has oneor more of a size and a shape selected to prevent passage of bone graftmaterial therethrough. In one embodiment, a width or a diameter of thevent port is less than approximately 2 mm. Optionally, the vent port 21includes a mesh or screen with apertures which allow passage of airtherethrough.

As illustrated in FIG. 75B, the vent port 21 can optionally have agenerally circular shape, such as a bore. Although the vent port 21illustrated in FIG. 75B is generally circular, other shapes arecontemplated. In one embodiment, the vent port is a slit or slot. Theslot may be generally linear. In another embodiment, the vent port 21has a shape that is generally triangular or rectangular. Specifically,the vent port 21 may have any size or shape which allows the passage ofair but prevents passage of bone graft material therethrough.

Any number of vent ports 21 may be formed through the hollow tube 2. Inone embodiment, the hollow tube 2 includes at least three vent ports 21.A first vent port 21A can be proximate to the proximal end 6 of thehollow tube 2. A second vent port 21B can be proximate to the distal end8. A third vent port 21C can be formed between the first and second ventports 21A, 21B.

Additionally, or alternatively, in another embodiment, the plunger 17includes a channel 35 (such as generally illustrated in FIG. 75A)configured to release air from the distal end 8 of the lumen 28 to theproximal end of the lumen. In this manner, as the plunger is advanced toeject bone graft material from the discharge opening 7, air trapped inthe bone graft material and/or the lumen distal end 8 (the portion ofthe lumen distal to the distal end 18 of the plunger 12) can passthrough the channel 35 into the proximal portion of the lumen.

Optionally, indicia 29 may be formed on one or more surface of thehollow tube 2. The indicia are configured to indicate a depth ofinsertion of the distal end 8 of the hollow tube into a surgical site.The indicia 29 can include marking and numerals. Optionally, one or moreof the indicia 29 may be radiopaque. The indicia 29 may extend along thelength of the hollow tube, or a predetermined portion of the length.

In one embodiment, the hollow tube 2 may comprise a first portion 22 anda second portion 23 which are configured to be interconnected. Thehollow tube 2 thus includes a joint 24, illustrated in FIG. 75C, alongwhich the first and second portions 22, 23 are connected. The joint 24may substantially bisect the hollow tube 2.

The first and second portions 22, 23 can be interconnected by anysuitable means. In one preferred embodiment, an ultraviolet activatedadhesive is used to interconnect the first and second portions 22, 23.This forms a particularly strong bond in combination with optionalalignment features 25, 26 (best seen in FIG. 75E) and the material ofthe hollow tube 2.

In another embodiment, the first and second portions 22, 23 aresonically welded together. Additionally, or alternatively, other gluesor adhesives can be used to join the first and second portions 22, 23.

Optionally, the first and second portions can include the alignmentfeatures 25, 26. In addition to ensuring alignment of the first portion22 with respect to the second portion 23 when the hollow tube 2 isassembled, the alignment features 25, 26 can also provide support to thehollow tube 2. In one embodiment, the alignment features 25, 26 have ashape selected to increase rigidity of the hollow tube 2, such as toprevent unintended or inadvertent bending or movement.

The alignment features 25, 26 may comprise a projection 25 formed on oneof the first and second portions 22, 23 that is at least partiallyreceived in a bore or aperture 26 of another of the first and secondportions 22, 23. In one embodiment, the alignment feature 25 comprises apeg or pin. Optionally, alignment feature 26 comprises a recessconfigured to receive the peg 25. In one embodiment, one of thealignment features 25, 26 comprises a flange. The flange may extendalong some or all of the joint 24. The other one of the alignmentfeatures 26, 25 may comprise a groove configured to receive the flange.Similar to the flange, the groove may extend along some or all of thejoint 24. Other shapes and features of the alignment features 25, 26 arecontemplated.

The alignment features 25, 26 can also be configured to lock the firstand second portion 22, 23 together. Specifically, in one embodiment,alignment feature 25 comprises a projection configured to engage acorresponding recess in alignment feature 26. Feature 26 canfrictionally engage feature 25.

The hollow tube 2 may be made of a flexible, semi-rigid, or rigidmaterial including one or more of a plastic, a composite, a metal. Inone embodiment, the hollow tube 2 is formed of polycarbonate resinthermoplastic. Optionally, at least a portion of the hollow tube 2 isradiopaque. In one embodiment, at least the distal end 8 is radiopaqueor includes radiopaque markers, such as indicia 29.

In one embodiment, the hollow tube 2 is substantially rigid. Optionally,at least a portion of the hollow tube 2 may be flexible. For example, inone embodiment, at least about one-half of the hollow tube 2 comprisingthe distal end 8 is flexible.

In one embodiment, the hollow tube 2 is generally linear. Alternatively,the hollow tube 2 can include a portion that is not linear. Morespecifically, in one embodiment, the hollow tube 2 can have a permanent(or temporary) curve or bend.

Alternatively, in another embodiment, the proximal end 6 of the hollowtube can extend along a first longitudinal axis. At least the distal end8 of the hollow tube 2 may extend along a second longitudinal axis thatis transverse to the first longitudinal axis of the proximal end. Thedistal end 8 can extend at a predetermined angle from the proximal end6. Optionally, the angle can be between about 0° and about 75°. In oneembodiment, the distal end 8 intersects the proximal end 6 at a joint.The joint may be adjustable such that a user can alter the angle betweenthe proximal end and the distal end. Alternatively, the joint is notadjustable. The proximal end and the distal end may each extendgenerally linearly to the joint. Alternatively, the hollow tube 2 mayinclude a transition portion between the proximal end and the distalend.

The transition portion can have a shape that is curved, such as an elbowjoint.

The hollow tube 2 may be made of a substantially transparent ortranslucent material. Accordingly, in one embodiment, the hollow tube isnot opaque. Optionally, at least a portion of the hollow tube 2 istransparent or translucent. In one embodiment, the hollow tube 2 iscomprised of a transparent or translucent material, or includes windowsof a transparent or translucent material. Accordingly, in embodiments,the plunger 12 is at least partially visible within the lumen 28.

Also, in another embodiment, the hollow tube 2 can include lightingelements 37. The lighting elements may be associated with the optionalendoscope, camera, or image sensor 36. Additionally, or alternatively,one or more lighting elements 37 can be fixed to, or integrally formedwith, the hollow tube 2. Suitable lighting elements, cameras, anddisplays that may be used with the integrated fusion cage and graftdelivery device 1 of the present disclosure are described in U.S. Pat.Nos. 8,864,654, 9,717,403, and PCT Pub. WO 2012/145048 which are eachincorporated herein by reference in their entirety.

As illustrated in FIGS. 75B, 75C, the funnel 30 can be releasablyinterconnected to the hollow tube. The funnel facilitates loading ofbone graft material into the opening 4 at the proximal end 6 of thehollow tube 2. Once the lumen 28 is loaded with bone graft material, thefunnel may be removed to improve visualization of the distal end 8 andopening 7 in a surgical site, such as a disc space. In contrast to priordevices which include a fixed funnel which cannot be removed, thereleasable funnel 30 of the present disclosure does not obstructvisualizing the distal end 8 of the hollow tube 2 as it is placed in adisc space or other surgical site. Optionally, if additional bone graftmaterial is required, the funnel 30 may be interconnected to the hollowtube during the surgical procedure without having to remove the hollowtube 2 from the surgical site, resulting in decreased potential traumato adjacent nerve tissue.

In one embodiment, the funnel 30 is retained on the hollow tube 2 by afriction fit. Alternatively, the funnel can snap onto the hollow tube.Optionally, in one embodiment, the hollow tube 2 include a collar 6Awith one or more projection 6B. The funnel 30 has a sleeve 32 that fitsover the collar and engages the projection 6B. Optionally, the sleeve 32includes a slot 33 to engage the projection 6B. The slot 33 andprojection 6B form a bayonet mount. In this manner, funnel can bereleasably interconnected to the hollow tube.

Optionally, the hollow tube 2 can be configured to receive a fusion cage60 of one or more of the embodiments described herein. Optionally, thefusion cage 60 may have a fixed height. Alternatively, the fusion cagemay be expandable after placement in a disc space.

In one embodiment, the fusion cage includes an opening 65 to dischargebone graft material therethrough. The opening 65 is alignable with theopening 7 of the hollow tube. Optionally, the fusion cage 60 may includetwo or more openings 65 which each correspond to openings 7A, 7B of thehollow tube. Accordingly, as bone graft material is advanced through thelumen and through the opening 7 of the hollow tube, the bone graftmaterial will be discharged through opening 65 of the fusion cage into asurgical site, such as a disc space.

In one embodiment, a distal end 64 of the fusion cage is closed. Thedistal end 64 may have a blunt or tapered shape similar to the wedgeshaped end 50 of the hollow tube.

In one embodiment of the device 1, the width of the hollow tube secondexterior surface 5 is between 9 and 15 mm. In a preferred embodiment,the width of the hollow tube second exterior surface 5 is between 11 and13 mm. In another embodiment, the width of the hollow tube secondexterior surface 5 is between 11.5 mm and 12.5 mm. In yet anotherembodiment, the width of the hollow tube second exterior surface 5 is 12mm.

In one embodiment of the device 1, the width of the hollow tube firstexterior surface 3 is between 5 and 11 mm. In another embodiment, thewidth of the hollow tube first exterior surface 3 is between 7 and 9 mm.Optionally, the width of the hollow tube first exterior surface 3 isbetween 7.5 mm and 8.5 mm. In one embodiment, the width of the hollowtube first exterior surface 3 is 8 mm.

In one embodiment of the device, the ratio of the width of the hollowtube second exterior surface 5 and the width of the hollow tube firstexterior surface 3 is between approximately 1.7 and 1.3. In anotherembodiment, the ratio of the width of the hollow tube second exteriorsurface 5 and the width of the hollow tube first exterior surface 3 isbetween 1.6 and 1.4. In still another embodiment, the ratio of the widthof the hollow tube second exterior surface 5 and the width of the hollowtube first exterior surface 3 is between 1.55 and 1.45. In oneembodiment, the ratio of the width of the hollow tube second exteriorsurface 5 and the width of the hollow tube first exterior surface 3 is1.5.

In one embodiment of the device, the width of the interior of the hollowtube major axis (located adjacent the second exterior surface 5) isbetween 9 and 13 mm. In another embodiment, the width of the interior ofthe hollow tube major axis is between 10 and 12 mm. Optionally, thewidth of the interior of the hollow tube major axis is between 10.5 mmand 11.5 mm. In one embodiment, the width of the interior of the hollowtube major axis is 11 mm.

In one embodiment of the device 1, the width of the interior of thehollow tube minor axis (located adjacent the first exterior surface 3)is between 5 and 9 mm. In another embodiment, the width of the interiorof the hollow tube minor axis is between 6 and 8 mm. In yet anotherembodiment, the width of the interior of the hollow tube minor axis isbetween 6.5 mm and 7.5 mm. In one embodiment, the width of the interiorof the hollow tube minor axis is 7 mm.

In one embodiment of the device 1, the ratio of the width of theinterior of the hollow tube major axis and the width of the interior ofthe hollow tube minor axis is between approximately 1.7 and 1.3. Inanother embodiment, the ratio of the width of the interior of the hollowtube major axis and the width of the interior of the hollow tube minoraxis is between

1.6 and 1.4. Optionally, the ratio of the width of the interior of thehollow tube major axis and the width of the interior of the hollow tubeminor axis is between 1.55 and 1.45. In one embodiment, the ratio of thewidth of the interior of the hollow tube major axis and the width of theinterior of the hollow tube minor axis is 1.5.

In one embodiment, one or more edges of the device are rounded. Forexample, the exterior edges of the hollow tube are rounded, and/or theinterior edges of the hollow tube are rounded (in which case the edgesof the plunger, at least at the plunger distal end, are identicallyrounded to ensure a congruous or conformal fit between the edges of theplunger and the interior of the hollow tube so as to, among otherthings, urge the majority of bone graft material to move through thehollow tube).

The device 1 may optionally be printed using a three-dimensionalprinting process. More specifically, one or more of the hollow tube 2,the plunger 12, the funnel 30, and the fusion cage 60 may bemanufactured by one or more three-dimensional printing processes. Avariety of materials, including a metal, PEEK, and other plastics may beused in a three-dimensional printer to form the device 1.

The integrated fusion cage and graft deliver device 1 of the presentinvention provides many benefits over other devices. For example, therectangular lumen 28 of embodiments of the hollow tube 2 affords severaladvantages over conventional circular configurations. For a surgicalarea with a smallest dimension set at a width of 8 mm and a thicknessdimension

0.5 mm, a conventional circular device (with resulting interior diameterof 7 mm or a radius of 3.5 mm) would realize a surface area of 38.48mm2. Applicants' device would carry interior dimension of 7 mm by 11 mmfor a surface area of 77 mm, an increased surface area factor of 2.0,thereby resulting in more bone graft material delivery, because, amongother things, a given volume of bone graft encounters less surface areaof the interior of a particular device which results in, among otherthings, reduced chance of jamming of bone graft material within thedevice.

Referring now to FIG. 76A, an integrated fusion cage and graft deliverdevice 1 according to embodiments of the present disclosure isillustrated delivering bone graft material 44 to a disc space 172 withina patient's spine 171. As shown, the hollow tube 2 of the device 1 isprovided with at least one opening 7. Bone graft material 44 is providedto the intervertebral space 172 by ejecting the material from theopening 7. In some embodiments, the hollow tube 2 has two openings suchthat bone graft material 44 is ejected on opposing sides of the device1. In this manner, the device 1 provides enhanced distribution of bonegraft material 44 and a greater quantity of bone graft material into asurgical site compared to other devices. Further, the largercross-sectional shape of the hollow tube 2 of the deliver tool 1 of thepresent invention allows injection of bone graft material in a thicker,more controllable viscous state and with less force than required byother devices.

An additional benefit of some embodiments of devices 1 of the presentdisclosure is that they avoid injection of bone graft material 44directly into the path or intended path of a cage, such as is the casewith other devices. For example, FIG. 76B provides a top view of thesurgical workspace 172 according to FIG. 76A, after the integratedfusion cage and graft deliver device 1 has been removed after insertionor injection of the bone graft material 44. As shown in FIG. 76B,removal of the bone graft delivery tool provides an unobstructed path174 and void space for subsequent insertion of a fusion cage (not shownin FIG. 76B). In this manner, devices 1 of the present disclosureprovide for a sufficient amount of bone graft material within thesurgical site 172 and provide an area 174 that is operable to receive afusion cage.

Referring now to FIG. 77, another embodiment of an integrated fusioncage and graft delivery device 1 of the present disclosure isillustrated. The integrated device 1 generally includes a hollow tube 2,a fusion cage 60, and a means for advancing bone graft material throughthe hollow tube. The means for advancing may use manual force,mechanical force, electric force, pneumatic force, or any other force toadvance bone graft material through the hollow tube. In one embodiment,a user can manipulate the integrated device 1 with a single hand. Thisbeneficially frees the user's other hand for other action.

In one embodiment, the means for advancing includes a handle or grip304. The grip 304 is operable to selectively move bone graft materialthrough the lumen of the hollow tube 2 for discharge from an opening 7at the tube distal end 8.

The hollow tube 2 includes a proximal end 6 configured to releasablyinterconnect to the grip 304. Bone graft material can be positionedwithin the lumen of the hollow tube 2, such as with a funnel 30(illustrated in FIG. 75B). The funnel 30 may then be removed from theproximal end 6. The proximal end 6 can then be interconnected to thegrip 304. Optionally, the hollow tube 2 can be used to eject bone graftmaterial into a surgical site without being affixed to the grip.

The grip 304 can frictionally engage the tube proximal end 6. In oneembodiment, the hollow tube 2 or the grip 304 include a lock or a latchto secure the hollow tube 2 to the grip. In another embodiment, aportion of the hollow tube 2 can threadably engage the grip 304. Inanother embodiment, the proximal end 6 and grip 304 are interconnectedwith a bayonet mount. Additionally, or alternatively, the grip 304 canoptionally include a knob 310 such that the hollow tube 2 can beselectively interconnected to the grip 304. Other means ofinterconnecting the hollow tube 2 to the grip 304 are contemplated.

A channel 324 is formed through the grip 304. The channel 324 includes aproximal opening 326 and extends through the grip 304 and the knob 310.In one embodiment, the opening 326 is configured to receive a plunger12. The plunger 12 can extend through the channel 324 into a hollow tube2 interconnected to the grip 304.

The grip 304 includes a means for advancing bone graft material throughthe lumen of the hollow tube 2. In one embodiment, the means foradvancing comprises a compressed fluid. Specifically, in one embodiment,the grip 304 is configured to advance the bone graft material using thecompressed fluid, such as air. Manipulating the grip trigger 306 canrelease compressed fluid into the proximal end 6 of the lumen. In oneembodiment, the hollow tube includes a single vent port 21B at thedistal end. When a proximal end of bone graft material within the lumenreaches the vent port 21B, the compressed fluid is released from thelumen.

In this manner, the fluid is not introduced into the surgical site.

Optionally, a pusher 18A may be positioned in the lumen of the hollowtube 2 after the lumen is loaded with bone graft material. The pusher18A may be similar to the distal end 18 of a plunger 12, such asgenerally illustrated in FIG. 75A. Regardless, the pusher 18A isconfigured to substantially conform to interior surfaces of the lumen.In this manner, the pusher 18A prevents the fluid from being dischargedfrom the opening 7 into the surgical site.

When a pressurized fluid is introduced into the lumen behind the pusher18A, the pusher advances toward the distal end 8. The bone graftmaterial is urged toward the distal end 8 and through the opening 7 bythe pusher. In one embodiment, when a proximal end of the pusher 18Aadvances past the vent port 21B, the compressed fluid is released fromthe lumen and the pusher stops. Alternatively, the pusher may stopadvancing by contact with an interior ramp 9 within the hollow tube 2.

In another embodiment, the means for advancing the bone graft materialcomprises a plunger 12. Accordingly, in one embodiment, the grip 304 isconfigured to selectively advance a plunger 12 through the lumen toadvance the bone graft material. The grip 304 is configured to advancethe plunger 12 axially with respect to the lumen of the hollow tube 2.Specifically, the grip can manipulate the plunger 12 such that a distalend of the plunger opposite the plunger handle 16 moves towards thedistal end 8 of the hollow tube 2. The grip 304 is configured tomanually or automatically apply a force to the plunger 12. The force canbe generated by one or more of a user, a motor, a compressed fluid, orany other means of generating a force.

In one embodiment, the plunger 12 includes teeth, notches 27, ordepressions which are engageable by the grip 304 to axially adjust theposition of the plunger 12. The notches can be substantially evenlyspaced along the plunger.

In one embodiment, a motor is positioned within the grip 304 to advancethe plunger. Optionally, the motor is operable to rotate a shaft. Theshaft may include a gear to translate the rotational movement into alinear movement of the plunger 12. In one embodiment, the gear includesteeth to engage the notches 27 or teeth of the plunger 12. A battery canprovide power to the motor. In one embodiment, the battery is housed inthe grip 304.

Optionally, the grip includes a gear or a ratchet configured to engageteeth, notches 27, or depressions on the plunger 12. Specifically, inone embodiment, the ratchet of the grip 304 is configured to engage theplurality of notches 27 formed in the plunger. In one embodiment, thechannel 324 of the grip 304 includes an aperture or window through whicha portion of the gear or ratchet can extend to engage the plunger 12.

In one embodiment, when activated, the ratchet engages a first notch andthen a second notch to incrementally advance the plunger distally withinthe hollow tube 2. Bone graft material within the hollow tube 2 is thenpushed by the plunger 12 toward the distal end 8 of the hollow tube.Ratcheting mechanisms that can be used with the grip 304 are known tothose of skill in the art. Some examples of ratcheting mechanisms aredescribed in U.S. Pat. App. Pub. 2002/0049448, U.S. Pat. App. Pub.2004/0215201, U.S. Pat. App. Pub. 2009/0264892, U.S. Pat. Nos.7,014,640, 8,932,295, 9,655,748, and 9,668,881 which are eachincorporated herein by reference in their entirety.

Optionally, the grip 304 can be configured to discharge a predeterminedamount of bone graft material each time the plunger 12 is incrementallyadvanced within the hollow tube. In one embodiment, between about 0.25and 1.0 cc of bone graft material is discharged from the distal end 8 ofthe hollow tube 2 each time the plunger is advanced. In anotherembodiment, between about 0.25 and 1.0 cc of bone graft material isdischarged is discharged each time the trigger 306 is actuated by auser.

The grip 304 can optionally be configured to enable vision of a surgicalsight by a user. Specifically, the grip 304 may be substantially evenwith one or more surfaces 3, 5 of the hollow tube. In this manner, inone embodiment, the grip 304 does not obstruction a line of sight alongat least one surface 3, 5. In another embodiment, an exterior surface ofthe grip is about even with a plane defined by one of the side surfaces3. Additionally, or alternatively, an upper portion of the grip does notextend beyond a plane defined by a top surface 5 of the hollow tube.Optionally, a window or view port is formed in the grip 304 to allowview of the distal end 8 of the hollow tube 2.

Additionally, or alternatively, a visualization system is associatedwith the hollow tube. In one embodiment, the visualization systemincludes (but is not limited to) one or more of a camera, a light, anendoscope, and a display. The visualization system may be permanently orremovably affixed to the integrated fusion cage and graft deliverydevice 1.

In one embodiment, the grip 304 includes a motor or other actuator whichcan be manipulated by a user to advance or withdraw the plunger in thehollow tube 2. The motor or actuator can operate the ratchet.

Optionally, the grip 304 is manually manipulated by a user to move theplunger 12. In one embodiment, the grip 304 includes a trigger 306. Thetrigger 306 may be hinged or pivotally interconnected to the grip 304.When the trigger 306 is actuated by a user, the plunger 12 is advancedin the hollow tube 2.

Actuating the trigger 306 may include pulling the trigger toward ahandle 308 of the grip. The trigger 306 can be biased away from thehandle 308 as generally illustrated in FIG. 78. Pulling the trigger 306toward the handle 308 causes the ratchet to engage the plunger 12. Theratchet engages a notch 27 of the plunger 12 and moves the plungertoward the distal end 8 of the hollow tube. Successively pulling thetrigger 306 incrementally advances the plunger 12 forward in the hollowtube.

In one embodiment, the ratchet is associated with an upper end of thetrigger 306. In this embodiment, pulling the trigger 306 causes theratchet to move toward the hollow tube 2. Optionally, a lock pawl (notillustrated) can be associated with the grip 304. The lock pawl canengage a notch of the plunger 12 to prevent inadvertent movement of theplunger distally.

The grip 304 can be used to advance or withdraw the plunger 12.Optionally, the grip 304 includes a switch 312 operable to change thedirection of movement of the plunger 12. By manipulating the switch 312,a user can cause the plunger 12 to advance into the hollow tube 2 or,alternatively, withdraw from the hollow tube. In one embodiment, towithdraw the plunger 12, the plunger handle 16 can be pulled away fromthe grip 304. The switch 312 may comprise a button.

The grip 304 can optionally include a loading port 314. The loading port314 provides access to the lumen of the hollow tube 2. In oneembodiment, the loading port 314 is in fluid communication with thechannel 324 through the grip 304. Accordingly, bone graft material canbe added to the hollow tube through the loading port 314. In oneembodiment, the loading port 314 is configured to engage a funnel 30 ofany embodiment of the present disclosure. Additionally, oralternatively, a syringe 42 may interconnect to the grip 304 todischarge bone graft material 42 into the lumen through the loadingport.

Additionally, or alternatively, a capsule or package 316 of bone graftmaterial can be loaded into the lumen through the loading port 314. Thepackage 316 can include any type of bone graft material, including oneor more of: autogenous (harvested from the patient's own body),allogeneic (harvested from another person), and synthetic. Apredetermined amount of bone graft material can be included in thepackage 316. In one embodiment, each package includes between about 0.25and 1.0 cc of bone graft material. One or more packages 316 may beloaded into the lumen to deliver a desired amount of bone graft materialto a surgical site.

Referring now to FIG. 78, still another embodiment of an integratedfusion cage and graft delivery device 1 of the present disclosure isillustrated. The device 1 illustrated in FIG. 78 is similar to thedevice 1 described in conjunction with FIG. 77 and includes many of thesame, or similar features. The integrated device 1 generally includes ahollow tube 2 configured to receive a fusion cage 60 and a means foradvancing bone graft material through the hollow tube for discharge outof an opening 65 of the fusion cage.

In one embodiment, the means for advancing includes a grip 304. The grip304 is configured to interconnect to a hollow tube 2 of any embodimentof the present disclosure. The grip 304 is operable to selectively movebone graft material through the lumen of the hollow tube 2 for dischargefrom the tube distal end 8. Bone graft material can be positioned withinthe lumen while the hollow tube 2 is interconnected to the grip 304.

The grip 304 can frictionally engage a predetermined portion of thehollow tube 2. In one embodiment, the hollow tube 2 or the grip 304include a lock or a latch to secure the hollow tube 2 to the grip.Optionally, the grip 304 engages at least the two side surfaces 3 of thehollow tube 2. In one embodiment, the grip 304 includes opposing flanges320. One or more of the flanges 320 can be moved inwardly toward thehollow tube similar to a clamp. In this manner, the flanges 320 canapply a compressive force to the side surfaces 3 to interconnect thehollow tube 2 to the grip. Other means of interconnecting the hollowtube 2 to the grip 304 are contemplated.

The grip 304 includes a means for advancing bone graft material throughthe lumen of the hollow tube 2. In one embodiment, the means foradvancing comprises a compressed fluid. Specifically, in one embodiment,the grip 304 is configured to advance the bone graft material using thecompressed fluid, such as air. Manipulating the grip trigger 306 canrelease compressed fluid into the proximal end 6 of the lumen. When apressurized fluid is introduced into the lumen, the plunger advancestoward the distal end 8. The bone graft material is urged toward thedistal end 8 and through the opening 65 by the plunger 12. In oneembodiment, the plunger may stop advancing by contact with an interiorramp within the hollow tube 2.

In another embodiment, the means for advancing the bone graft materialis configured to selectively advance the plunger 12 through the lumen toadvance the bone graft material. Specifically, the grip 304 isconfigured to manually or automatically apply a force to the plunger 12.The force can be generated by one or more of a user, a motor, acompressed fluid, or any other means of generating a force.

In one embodiment, a motor is positioned within the grip 304 to advancethe plunger. Optionally, the motor is operable to rotate a shaft. Theshaft may include a gear to translate the rotational movement of theshaft into a linear movement of the plunger 12. In one embodiment, theplunger includes notches to engage the gear of the shaft. A battery canprovide power to the motor. In one embodiment, the battery is housed inthe grip 304.

In one embodiment, the plunger 12 includes teeth, notches, ordepressions which are engageable by the grip 304 to axially adjust theposition of the plunger 12. Optionally, the grip includes a gear or aratchet configured to engage teeth or notches on the plunger 12.Specifically, in one embodiment, the ratchet of the grip 304 isconfigured to engage a plurality of notches formed in the plunger. Thenotches can be substantially evenly spaced along the plunger. Theratchet engages a first notch and then a second notch to incrementallyadvance the plunger distally within the hollow tube 2. Bone graftmaterial within the hollow tube 2 is then pushed by the plunger 12toward the distal end 8 of the hollow tube.

The grip 304 is configured to enable vision of a surgical sight by auser. Specifically, in one embodiment, the grip 304 does not extendabove a top surface 5 of the hollow tube. In this manner, in oneembodiment, the grip 304 does not obstruction a line of sight along atleast the top surface 5. In another embodiment, lateral surfaces of thegrip are about even with a plane defined by one of the side surfaces 3of the hollow tube.

In one embodiment, the grip 304 includes a motor or other actuator whichcan be manipulated by a user to advance or withdraw the plunger in thehollow tube 2. The motor or actuator can operate the ratchet.

Optionally, the grip 304 is manually manipulated by a user to move theplunger 12. In one embodiment, the grip 304 includes a trigger 306. Thetrigger 306 may be hinged or pivotally interconnected to the grip 304.When the trigger 306 is actuated by a user, the plunger 12 advances inthe hollow tube 2. Specifically, in one embodiment, the trigger 306 isfunctionally interconnected to the plunger 12.

In one embodiment, actuating the trigger 306 includes pulling thetrigger toward a handle 308 of the grip. The trigger 306 can be biasedaway from the handle 308 as generally illustrated in FIG. 79. In oneembodiment, pulling the trigger 306 toward the handle 308 causes theratchet to engage the plunger 12. The ratchet engages a notch of theplunger 12 and moves the plunger toward the distal end 8 of the hollowtube. Successively pulling the trigger 306 incrementally advances theplunger 12 forward in the hollow tube.

In one embodiment, the ratchet is associated with an upper end of thetrigger 306. In this embodiment, pulling the trigger 306 causes theratchet to move toward the distal end of the hollow tube 2. Optionally,a lock pawl (not illustrated) can be associated with the grip 304. Thelock pawl can engage a notch of the plunger 12 to prevent the plungerfrom moving distally.

The grip 304 can be used to advance or withdraw the plunger 12.Optionally, the grip 304 includes a switch operable to change thedirection of movement of the plunger 12. By manipulating the switch, auser can cause the plunger 12 to advance into the hollow tube 2 or,alternatively, withdraw from the hollow tube. In one embodiment, towithdraw the plunger 12, the plunger handle 16 can be pulled away fromthe grip 304.

Additionally, or alternatively, the grip 304 can include a knob 318. Inone embodiment, the knob 318 is configured to advance or withdraw theplunger 12 within the hollow tube 2. Specifically, rotating the knob ina first direction causes the plunger 12 to advance toward the distal end8. Rotating the knob 318 in a second direction causes the plunger 12 towithdraw away from the distal end 8.

In one embodiment, the knob 318 includes a gear, such as a pinion. Thegear includes teeth that engage notches or teeth extending linearlyalong the plunger 12, similar to a rack. Rotational movement of the knob318 is converted into linear motion of the plunger by interactionbetween the knob pinion with the plunger rack.

Optionally, the hollow tube 2 may discharge a predetermined amount ofbone graft material associated with each rotation, or partial rotationof the knob 318. Specifically, a calibrated amount of bone graftmaterial may be discharged from the hollow tube 2 for each quarter,half, or full rotation of the knob 318. In one embodiment, the hollowtube 2 is configured to discharge approximately 1 cc of bone graftmaterial for each half turn of the knob 318.

In one embodiment, the knob 318 is configured to provide tactilefeedback to a user after a predetermined amount of rotation. Forexample, when the knob is rotated one or more of ⅛, ¼, ½, and 1 turn,the knob and/or the grip 304 may vibrate or provide other tactilefeedback to the user.

The grip 304 is also operable to expand the fusion cage 60 and separatethe fusion cage 60 from the hollow tube. In one embodiment, the knob 318can slide within a slot 322 to release the fusion cage 60. In oneembodiment, pulling the knob 318 away from the distal end 8 of thehollow tube detaches the fusion cage.

Referring now to FIG. 79, an embodiment of a graft delivery device 1 ofthe present disclosure is illustrated. In this embodiment, the cannula 2comprises a distal tube 501, a proximal interior tube 502, and a breecharea 503. In the embodiment illustrated in FIG. 79, the distal tube 501is injection-molded and has an inner cross-section of about 4 mm×7 mmand an outer cross-section of about 6 mm×9 mm, but it is to be expresslyunderstood that the distal tube 501 may be manufactured by any suitablemeans and may have any suitable size and shape. The proximal interiortube 502 may also be injection-molded, and securely interconnects to thedistal tube 501 by mechanisms described in greater detail below. Thebreech area 503, disposed on a top aspect of the proximal interior tube502, allows for loading of graft material into the proximal interiortube 502 by mechanisms described in greater detail below.

Referring now to FIG. 80, a proximal portion of the graft deliverydevice 1 depicted in FIG. 79 is illustrated. As illustrated in FIG. 80,the graft delivery device 1 of this embodiment may comprise either orboth of two mechanisms for loading graft material into the proximalinterior tube 502: a funnel 30, as shown and described elsewherethroughout this description, and the breech area 503. As illustrated inFIG. 80, the breech area 503 may generally take the form of a hingeddoor or cover, interconnected to lateral walls of the proximal interiortube 502 by a breech hinge 504, which may be adapted to open upwardly in“trap door”-like fashion by rotating about the breech hinge 504 to allowa surgeon or other user to load fibrous or standard graft material intoan interior volume of the proximal interior tube 502, and may be furtheradapted to close downwardly by rotating about the breech hinge 504 toseal the graft material within the proximal interior tube 502 and/orprevent other materials from entering the proximal interior tube 502.The breech hinge 504 may, in addition to providing a secureinterconnection between the breech area 503 and walls of the proximalinterior tube 502, be further configured to securely lock, affix, and/orinterconnect the proximal interior tube 502 to the distal tube 501. Toprevent inadvertent or undesired opening of the breech area 503, thegraft delivery device 1 may be further provided with an optional breechlock 505, which may serve to lock the breech area 503 in a closedposition by any suitable mechanism, e.g. a spring-loaded mechanism (notshown).

Referring now to FIG. 81, one possible geometry for the secureinterconnections between any two or more of the distal tube 501, theproximal interior tube 502, and the breech area 503 is illustrated. Asillustrated, the proximal interior tube 502 may, in at least a distalportion, have a larger outer diameter and/or a larger inner diameterthan a corresponding outer and/or inner diameter of at least a proximalportion of the distal tube 501, and the distal portion of the proximalinterior tube 502 may be adapted to receive therein the proximal portionof the distal tube 501. The distal portion of the proximal interior tube502 may be adapted to surround the proximal portion of the distal tube501 about substantially all, or less than substantially all, of acircumference of the proximal portion of the distal tube 501. Asillustrated in FIG. 81, in a preferred embodiment, the distal portion ofthe proximal interior tube 502 may surround the proximal portion of thedistal tube 501 about three out of four sides (left, right, and bottomsides) of the rectangular cross-section of the distal tube 501, whilethe fourth (top) side of the proximal portion of the distal tube 501 isproximate to and enclosed by at least a portion of the breech area 503.

Referring now to FIGS. 82A and 82B, further features of the embodimentof the graft delivery device 1 depicted in FIGS. 79-81 are illustrated.In this embodiment, a vertically extending rail 506 is disposed withinan interior volume of the proximal interior tube 502. As illustrated inFIG. 82A, the vertically extending rail 506 provides a greater verticaldepth to the interior volume of the proximal interior tube 502 andthereby allows for a greater volume of graft material to be insertedinto the proximal interior tube 502, and as illustrated in FIG. 82B, therail 506 snugly mates with the breech area 503 when the breech area 503is in the closed position so as to securely enclose the interior volumeof the proximal interior tube 502. As further illustrated in FIG. 82A,distally extending portions of the proximal interior tube 502 may“sandwich” the breech area 503 at the breech hinge 504 to ensure thatthe proximal interior tube 502, breech area 503, and distal tube 501 areall securely affixed at the breech hinge 504.

Referring now to FIGS. 83A and 83B, one embodiment of a mechanism forsecurely interconnecting the distal tube 501, the proximal interior tube502, and the breech area 503 is illustrated. As illustrated in FIG. 83A,the distal portion of the proximal interior tube 502 has a generallysmooth inner surface, providing for a smooth and contiguous bore andtherefore the least resistance to the flow of bone graft materialthrough the graft delivery device 1. The proximal portion of the distaltube 501 is locked into place within the proximal interior tube 502;this is achieved by closing the breech area 503, which causes at leastone cavity 502 a in the proximal interior tube 502 and at least onecavity 503 a in the breech area 503 to interface and interlock with aknuckle 501 a of the distal tube 501. This interaction between thecavities 502 a, 503 a and the knuckle 501 a is shown in greater detailin the perspective view of FIG. 83B. As illustrated, the knuckle 501 acomprises a vertical rise or protrusion on a top face of an outersurface of the proximal end of distal tube 501. The cavity 503 a of thebreech area 503, meanwhile, takes the form of a recessed or “cut-out”portion of the breech area 503, i.e. a region where a thickness of thebreech area 503 is reduced; the knuckle 501 a thus mates with and snuglyfits within the cavity 503 a, so as to securely interconnect the distaltube 501, the proximal interior tube 502, and the breech area 503 whileproviding a substantially uniform height of the cannula 2 and asubstantially unimpeded flow path for bone graft material within thecannula 2.

Other arrangements of the distal tube 501, the proximal interior tube502, and the breech area 503 are possible according to the presentdisclosure. As a non-limiting example, the breech hinge 504 may beplaced in another location along the breech area 503, such as closer toa proximal end thereof.

In various embodiments a bone graft tamping device may also be provided,which is adapted to be inserted into the hollow tube 2 after the plunger12 is removed from the hollow tube. The bone graft tamping device,according to this embodiment, may include one or more longitudinalchannels along the outer circumference of the bone graft packer forpermitting any trapped air to flow from the bone graft receiving area tothe graspable end of the hollow tube during packing of bone graft. Thebone graft packer may further include a handle at one end designedergonomically for improving ease of use. The bone graft packer in thisembodiment thereby facilitates packing of bone graft within the hollowtube.

The hollow tube 2 may also be fitted with a passageway wherein asurgical tube or other device may be inserted, such as to deliver aliquid to the surgical area or to extract liquid from the surgical area.In such an embodiment, the plunger 12 is adapted in cross-section toconform to the hollow tube's cross-section.

In another embodiment of the present invention, a kit of surgicalinstruments comprises a plurality of differently sized and/or shapedhollow tubes 2 and a plurality of differently sized and/or shapedplungers 12. Each of the plungers correspond to at least one of thehollow tubes, whereby a surgeon may select a hollow tube and a plungerwhich correspond with one another depending upon the size and shape ofthe graft receiving area and the amount or type of bone graft to beimplanted at such area. The corresponding hollow tubes and plungers areconstructed and arranged such that bone graft can be placed within thehollow tubes with the plungers, and inserted nearly completely into thehollow tubes for removing substantially all of the bone graft materialfrom the hollow tubes, such as in the preferred embodiments for theplunger described above. The use of more than one hollow tube/plungercombination permits at least two different columns of material to beselectively delivered to the targeted site, e.g. one of bone graftmaterial from the patient and another of Bone Morphogenetic Protein(BMP), or e.g. two different types of bone graft material or onedelivering sealant or liquid. Also, one or both hollow tubes could bepreloaded with bone graft material.

The kit of surgical instruments may comprise a plurality of differentlysized and/or shaped graft retaining structures, each corresponding to atleast one hollow tube and at least one plunger.

The bone graft receiving area can be any area of a patient that requiresdelivery of bone graft. In the preferred embodiment, the bone graft isdelivered in a partially formed manner, and in accordance with anotheraspect of the present invention, requires further formation afterinitial delivery of the bone graft.

Another embodiment of the present invention provides a method by which ahollow tube and a plunger associated with the hollow tube are providedto facilitate delivery of the bone graft to a bone graft receiving area.

According to one embodiment, the present invention provides a bone graftdelivery system, by which a hollow tube and/or plunger assembly may beprepared prior to opening a patient, thus minimizing the overall impactof the grafting aspect of a surgical implantation or other procedure.Moreover, the hollow tube 2 may be made to be stored with bone graft init for a period of time, whether the tube is made of plastic, metal orany other material. Depending upon the surgical application, it may bedesirable to only partially fill the tube for storage, so that a plungercan be at least partially inserted at the time of a surgery.

Thus, the integrated fusion cage and graft delivery device 1 may eithercome with a pre-filled hollow tube, or a non-filled hollow tube, inwhich the surgeon will insert bone graft received from the patient(autograft), or from another source (allograft). In either case, thesurgeon may first remove any wrapping or seals about the hollow tube,and/or the pre-filled bone graft, and insert the hollow tube into thepatient such that the second end of the hollow tube is adjacent the bonegraft receiving area. Once the hollow tube is in place, and the openingat the second end of the hollow tube is oriented in the direction of thedesired placement of bone graft, the surgeon may then insert the secondend of the plunger into the opening at the first end of the hollow tube,and begin pressing the second end of the plunger against the bone graftmaterial in the hollow tube. In this fashion, the plunger 12 and hollowtube 2 cooperate similar to that of a syringe, allowing the surgeon tosteadily and controllably release or eject bone graft from the secondend of the hollow tube as the plunger is placed farther and farther intothe opening in the hollow tube. Once the desired amount of bone grafthas been ejected from the hollow tube (for in some instances all of thebone graft has been ejected from the hollow tube) the surgeon may removethe plunger from the hollow tube, and complete the surgery. In certainoperations, the surgeon may elect to place additional bone graft intothe hollow tube, and repeat the steps described above. Furthermore, thepre-filled bone graft elements may be color-coded to readily identifythe type of bone graft material contained therein.

According to the embodiment described in the preceding paragraph, thepresent invention may be carried out by a method in which access isprovided to a graft receiving area in a body, bone graft is placed intoa hollow tube having a first end and a second end, the hollow tube,together with the bone graft, is arranged so that the first end of thehollow tube is at least adjacent to the graft receiving area and permitslateral or nearly lateral (in relation to the longitudinal axis of thehollow tube and plunger assembly) introduction of bone graft to thegraft receiving area. This method prevents loss of bone graft due toimproper or limited orientation of the integrated fusion cage and graftdelivery device, and further allows a user to achieve insertion of adesired quantity of bone graft by way of the contoured plunger andhollow tube configuration described according to preferred embodimentsherein.

The method of the present invention may also be carried out by providinga hollow tube having a first end and a second end, constructed so thatit may receive a measurable quantity of bone graft, and so that thefirst end may be arranged at least adjacent to a bone graft receivingarea, and so that bone graft can be delivered from the first end of thehollow tube through the second end of the hollow tube and eventually tothe bone graft receiving area upon movement of the plunger in agenerally downward direction through the hollow tube (i.e., in adirection from the first end to the second end). According to thisembodiment, a graft retaining structure may also be provided for use inconnection with the contoured edge of the plunger, such that the graftretaining structure is positioned between the contoured edge of theplunger and the bone graft, but which is adhered to the bone graft andremains at the graft receiving area following removal from the hollowtube. In one embodiment, the bone graft is provided in discrete packagesor containers. Furthermore, this graft retaining structure may also beemployed with another tool, such as a graft packer, which is employedeither before or after the hollow tube is removed from the graftreceiving area.

In another embodiment, the one or more plungers corresponding to the oneor more hollow tubes are positioned with distal ends near the proximateend of the horizontal tube before use, the plungers having a detent toretain plunger in ready position without undesired movement beforesurgeon chooses which one or more plungers to extend through hollowhorizontal tube and deliver bone graft material and/or desired materialto the surgical area.

According to another embodiment of the present invention, a hollow tubeand plunger assembly is provided in which the hollow tube and/or theplunger assembly is disposable. Alternatively, the tube may be made of abiocompatible material which remains at least partially in the patientwithout impairing the final implantation. Thus, the hollow tube may beformed from a material that is resorbable, such as a resorbable polymer,and remain in the patient after implantation, so as not to interferewith the growth of the bone or stability of any bone graft or implant.

The current design preferably comprises a hollow tubular membercomprising a rounded edge rectangular shaft, which may be filled or ispre-filled with grafting material. The loading is carried out by theplunger. The rectangular design is preferable as it allows the largestsurface area device to be placed into the annulotomy site of a disc, butin other embodiments may be formed similar to conventional round shafts.The other preferred feature includes a laterally-mounted exit site forthe graft material. The combination of this design feature allowsdirection-oriented dispersion of the graft material. This allowsejection of the graft material into an empty disc space as opposed tobelow the hollow tube, which would tend to impact the material and notallow its spread through a disc space.

Another feature of this design is that a rectangular design allows theuser to readily determine the orientation of the device and thereby thedirection of entry of the bone graft material into the surgical area.However, such a feature may be obtained alternatively through exteriormarkings or grooves on the exterior on the hollow tube. Such exteriorgrooves or markings would allow use of a range of cross-sections for thedevice, to include a square, circle, or oval while allowing the user toreadily determine the orientation of the device relative to thedirection of entry of the bone graft material into the surgical area.

A further feature of this design is that an anti-perforation footing orshelf is paced on the bottom of the hollow tube to prevent annularpenetration and/or injury to the patient's abdomen or other anatomyadjacent the bone graft receiving area.

In another embodiment of the invention, all or some of the elements ofthe device or sections of all or some of the device may be disposable.Disposable medical devices are advantageous as they typically havereduced recurring and initial costs of manufacture.

In another embodiment of the device, the distal tip or end of theplunger device is composed of a different material to the rest of theplunger, so as the material at the distal end of the plunger issponge-like or softer-than or more malleable than the rest of theplunger so as upon engagement with the interior distal end of the hollowtube, the distal end of the plunger substantially conforms to theinterior configuration of the hollow tube. Similarly, the plunger distalend may be made of a material that is adaptable to substantially conformto the interior shape of the distal end of the hollow tube. Suchconfigurations enable substantially all of the material contained withinthe plunger to be delivered to the targeted site.

Another alterative embodiment to the design described herein includes anavigation aid 29 on one or more surfaces of the hollow tube 2 to permitsurgeon to know how far the device 1 has been inserted or to ensureproper alignment relative to a transverse bone graft delivery site (i.e.disc space). Such capability is particularly important when the patientor surgical area is not positioned immediately below the surgeon, ormultiple procedures are being performed. A navigation aid allows moreimmediate and reliable locating of the surgical area for receiving ofbone graft material. In one embodiment, the hollow tube 2 is scored ormarked 29 or provides some affirmative indication, actively orpassively, to the surgeon to indicate degree of delivery of thematerial, e.g. bone graft material, to the delivery site, and/orposition of the plunger 12. For example, the exterior of the hollow tubecould be color-coded and/or provided with bars 29. In anotherembodiment, a computer and/or electro-mechanical sensor or device isused to provide feedback to the surgeon to indicate degree of deliveryof the material, e.g. amount of cc's of bone graft material, to thedelivery site, and/or position of the plunger element.

In another alterative embodiment to the design described herein, theplunger 12 could include an activation device, which is often in aliquid or semi-liquid state, and that may be injected once thesemi-solid portion of the morphogenic protein has been displaced by themovement of the plunger through the hollow tube 2. That is, the plunger12 pushes the dry material, and once completed has a bulb or otherdevice on the usable end to insert the liquid portion of the activatingagent through the inner lumen 28 within the plunger 12 to evacuate theliquid from the plunger and out an opening at the non-usable end of theplunger so as to contact the dry material already inserted into the discspace).

In one embodiment of the device, all or portions of the device 1 aremanufactured using 3-D printing techniques. In another embodiment, allor portions of the device are made by injection molding techniques.

In one embodiment, the ratio of the surface area of the bottom tip ofthe plunger 12 is approximately half the surface area of the two lateralopenings at the distal portion of the hollow tube.

In one embodiment, the device 1 includes a supplemental means ofgripping the device, such as a laterally extending cylindrically-shapedhandle that engages the hollow tube 2.

In one embodiment, the material inserted into the hollow tube 2 is anon-Newtonian fluid. In one embodiment, the device is adapted to acceptand deliver compressible fluids. In another embodiment, the device isadapted to accept and deliver non-compressible fluids. The hollow tube 2of one embodiment includes a rectangular lumen 28 which provides anincreased cross-sectional footprint relative to a round lumen of otherbone graft delivery devices. The increased cross-sectional footprintdecreases friction of the non-Newtonian fluid material against theinterior walls of the lumen, resulting in an improved flow of bone graftmaterial through the lumen and eliminating (or reducing) jamming duecompression of the bone graft material. The increased cross-section ofhollow tube 2 of the present disclosure improves the flow dynamics of anon-Newtonian fluid by 40% compared to a prior art tool with a diameterequal to the height of the rectangular lumen of embodiments of thepresent invention.

In one embodiment, the upper portion of plunger is fitted with one ormore protrusions, which extends from the surface of the plunger so as toengage the upper surface of the hollow tube, to prevent the plunger fromengaging the distal interior portion of the hollow tube. In oneembodiment, the upper portion of plunger is fitted with one or moreprotrusions to prevent the plunger from engaging the apex of the hollowtube distal interior ramp surface.

In one embodiment, the funnel 30 attaches to the hollow tube 2 by abayonet connection. In one embodiment, the funnel attaches to the hollowtube by an interference fit. In one embodiment, the funnel attaches tothe hollow tube by a threaded connection. In one embodiment, the funnelattaches to the hollow tube by a slot/groove connection.

In one embodiment, the distal end 8 of hollow tube has one opening 7. Inone embodiment, the hollow tube 8 has two distal openings 7A, 7B locatedon opposite sides. In one embodiment, the hollow tube has no more thantwo openings 7, the openings located on opposite sides.

In one embodiment, after bone graft material 44 is delivered to asurgical site 172, a cavity 174 approximately defined by the volumeengaged by the device 1 when inserted into the surgical site is left inthe surgical site upon removal of the device from the surgical site. Inone embodiment, the cavity 174 is then used as the site for insertion ofa fusion cage 60.

The integrated fusion cage 60 with expandable cage feature provides anumber of unique and innovative features not provided by conventional ortraditional integrated fusion cages. For example, the integrated fusioncage with expandable cage feature of the disclosure is intentionally anddeliberately designed to receive bone graft material (or any materialsuitable for use in surgical applications, as known to those skilled inthe art) at its proximal end (i.e. the end generally facing the surgeonand/or the end opposite the end initially directed into a surgicalsite), such that the bone graft material flows into the fusion cage andalso flows out from the fusion cage into the surgical site. Suchfeatures as the interior ramps of the fusion cage (e.g. located withinthe interior of the hollow tube, and/or on the front and/or rear blocksof the fusion cage) function to direct received bone graft material intothe surgical site. Additionally, the features of the hollow tube andplunger wherein a greater volume of bone graft material may be reliably(e.g. not prone to blockage as is typical with most convention e.g.round hollow tubes or lumen systems) and readily delivered to a surgicalsite and/or a fusion cage are unique and not found in the prior art.Among other things, such features encourage improved surgical results bydelivering more volume and coverage of bone graft material to thesurgical site. Also, such features minimize gaps in bone graft coverageto include gaps between the fusion cage area and the surroundingsurgical site. Also, the features of the one or more apertures of thefusion cage of the disclosure enable and encourage delivery of bonegraft material, as received by the fusion cage, into the surroundingsurgical site.

In contrast, conventional fusion cages, to include expandable fusioncages, do not provide such features and/or functions. For example, U.S.Pat. No. 8,852,242 to Morgenstern Lopez (“Lopez”), discloses a dilationintroducer for orthopedic surgery for insertion of an intervertebralexpandable fusion cage implant. The Lopez device does not allow receiptof bone graft material from its proximal end, or any end, in contrast tothe disclosed fusion cage and fusion cage/bone graft delivery system.That is, the Lopez proximal end includes an array of components, all ofwhich do not allow receipt of bone graft material. Furthermore, theLopez device requires an elaborate array of components, e.g. upper sideportion of the upper body portion and lower side portion of the lowerbody portion, which also block any egress of bone graft from the insideof the Lopez fusion cage once deployed. Also, the Lopez wedges occupythe entire interior of the cage; there are no ramps to direct graft fromthe interior to the disk space. In short, the Lopez design is not madewith bone graft delivery in mind, and indeed, cannot function to acceptlet alone deliver bone graft. Additionally, suggestions provided in theLopez disclosure to deliver bone graft to the surgical site would notprovide the integrated and complete fusion cage and surgical site bonegraft delivery of the invention, e.g. the Lopez slot of the Lopez lumenand funnel assembly at best provides limited delivery of bone graftmaterial only before and after insertion of the Lopez fusion cage, andthen only peripheral to the fusion cage. Also, it appears the Lopezdevice provides wedges and of similar if not identical interior rampangles. In contrast, in certain embodiments of the present invention theinterior wedged surfaces of the invention, i.e. front block ramp 226 andrear block ramp 236, are not of the same configuration and/or shape,e.g. front block ramp 226 is of a curved profile and rear block ramp 236is of a linear or straight-line profile. Among other things, the curvedprofile of the front block ramp 226 urges egress of bone graft asreceived by the fusion cage 60.

In one embodiment of the fusion cage 60, no anti-torque structures orcomponents are employed. In one embodiment of the invention, the lateralsides of the fusion cage 60 are substantially open to, among otherthings, allow egress of bone graft material as received to the fusioncage. In one embodiment, the expansion screw 240 is configured with alocking mechanism, such that the fusion cage 60 may be locked at a setexpansion state. In one embodiment, such a locking mechanism is providedthrough a toggle device operated at or on the installer/impactor handle258.

In one embodiment, the front block ramp 226 and rear block ramp 236 areidentical and/or symmetrical.

In addition, it is contemplated that some embodiments of the fusion cage60 can be configured to include side portions that project therefrom andfacilitate the alignment, interconnection, and stability of thecomponents of the fusion cage 60.

Furthermore, complementary structures can also include motion limitingportions that prevent expansion of the fusion cage beyond a certainheight. This feature can also tend to ensure that the fusion cage isstable and does not disassemble during use.

In some embodiments, the expansion screw 240 can facilitate expansion ofthe fusion cage 60 through rotation, longitudinal contract of a pin, orother mechanisms.

The expansion screw 240 can also facilitate expansion throughlongitudinal contraction of an actuator shaft as proximal and distalcollars disposed on inner and outer sleeves move closer to each other toin turn move the proximal and distal wedged block members closertogether. It is contemplated that in other embodiments, at least aportion of the actuator shaft can be axially fixed relative to one ofthe proximal and distal wedge block members with the actuator shaftbeing operative to move the other one of the proximal and distal wedgemembers via rotational movement or longitudinal contraction of the pin.

Further, in embodiments wherein the engagement screw 240 is threaded, itis contemplated that the actuator shaft can be configured to bring theproximal and distal wedged block members closer together at differentrates. In such embodiments, the fusion cage 60 could be expanded to aV-configuration or wedged shape. For example, the actuator shaft cancomprise a variable pitch thread that causes longitudinal advancement ofthe distal and proximal wedged block members at different rates. Theadvancement of one of the wedge members at a faster rate than the othercould cause one end of the implant to expand more rapidly and thereforehave a different height that the other end. Such a configuration can beadvantageous depending on the intervertebral geometry and circumstantialneeds.

In other embodiments, an upper plate 200 can be configured to includeanti-torque structures. The anti-torque structures can interact with atleast a portion of a deployment tool during deployment of the fusioncage 60 implant to ensure that the implant maintains its desiredorientation. For example, when the implant is being deployed and arotational force is exerted on the actuator shaft, the anti-torquestructures can be engaged by a non-rotating structure of the deploymenttool to maintain the rotational orientation of the implant while theactuator shaft is rotated. The anti-torque structures can comprise oneor more inwardly extending holes or indentations on the rear wedgedblock member. However, the anti-torque structures can also comprise oneor more outwardly extending structures.

According to yet other embodiments, the fusion cage 60 can be configuredto include one or more additional apertures to facilitateosseointegration of the fusion cage 60 within the intervertebral space.The fusion cage 60 may contain one or more bioactive substances, such asantibiotics, chemotherapeutic substances, angiogenic growth factors,substances for accelerating the healing of the wound, growth hormones,antithrombogenic agents, bone growth accelerators or agents, and thelike. Indeed, various biologics can be used with the fusion cage 60 andcan be inserted into the disc space or inserted along with the fusioncage 60 The apertures can facilitate circulation and bone growththroughout the intervertebral space and through the implant. In suchimplementations, the apertures can thereby allow bone growth through theimplant and integration of the implant with the surrounding materials.

In one embodiment, the fusion cage 60 comprises an expandable cageconfigured to move a first surface vertically from a second surface byrotation of at least one screw that rotates without moving transverselywith respect to either the first or second surface, the first plate andsecond plate having perimeters that overlap with each other in avertical direction and that move along a parallel line upon rotation ofthe screw.

In one embodiment, the fusion cage 60 is stackable by any means known tothose skilled in the art. For example, each upper plate 200 may befitted with one or more notches on the lateral edges configured to fitwith one or more protrusions on each lower plate 210.

Surprisingly, while conventional practice assumed that the amount ofmaterial that would be required, let alone desired, to fill a prepareddisc space with bone paste (or BMP, etc.) would be roughly equivalent tothe amount of material removed from such space prior to inserting acage, a present inventor discovered that far more bone graft materialcan be—and should preferably be—inserted into such space to achievedesired fusion results. The reasons why this basic under appreciationfor the volume of bone graft necessary to achieve optimal fusion resultsvary, but the clinical evidence arrived at via practice of the presentinvention compellingly demonstrates that more than doubling of theamount of bone graft material (and in some cases increasing the amountby 200%, 300% or 400% or more) than traditionally thought necessary orsufficient, is extremely beneficial to achieving desired results fromfusion procedures.

The ramifications of this simple yet dramatic discovery (documented inpart below) is part of the overall inventive aspect of the presentinvention, as it has been—to date—simply missed entirely by thepracticing spine surgeons in the field. The prospect of reduced returnsurgeries, the reduction in costs, time, and physical suffering bypatients, as well as the volume of legal complaints against surgeons andhospitals due to failed fusion results, is believed to be significant,as the evidence provided via use of the present invention indicates avast reduction in the overall costs involved in both economic resources,as well as emotional capital, upon acceptance and wide-spread use of thepresent invention. Insurance costs should thus decrease as the presentinvention is adopted by the industry. While the costs of infusingincreased amount of bone graft materials into the space of a patient'sdisc may at first appear to increase the costs of an individualoperation, the benefits achieved thereby will be considerable, includingthe reduction of repeat surgeries to fix non-fused spines. Thus,regardless of the actual tools and devices employed to achieve the endresult of attaining up to 100% more bone graft material being utilizedin fusion operations, (as well as other surgeries where previouslyunder-appreciated bone graft material delivery volumes have occurred)one important aspect of the present invention is directed to theappreciation of a previously unrecognized problem and the solutionthereto, which forms part of the inventive aspects of the presentinvention described and claimed herein.

In one embodiment, at least twice the amount of disc material removedfrom a surgical site is replaced with bone graft material. In apreferred embodiment, at least three times the amount of disc materialremoved from a surgical site is replaced with bone graft material. In amost preferred embodiment, at least three and a half times the amount ofdisc material removed from a surgical site is replaced with bone graftmaterial.

Experimental Results

The following experimental results are with respect to an apparatus andmethod for near-simultaneous and integrated delivery of bone graftmaterial in a patient's spine. These results are sample results and arenot intended to limit the invention.

Materials and Methods

During the time period from July 2010 through December 2012, a set ofpatients undergoing minimally invasive (MIS) transverse lumbar interbodyfusion (T-LIF) at the L4-5 and/or L5-S1 levels were studied for diskmaterial removed and BG delivered at each disk space during the surgicalprocedure. The diagnosis was spondylosis or spondylolisthesis in allpatients. A total of 63 patients with an average age of 56 years werestudied. There were 29 male and 34 female patients. Ninety-one diskspaces were analyzed. A single surgeon with the same surgical teamperformed all surgeries. The operations were carried out through a 22 mmcannula with microscopic control. The midline structures and spinousprocess attachments were left undisturbed. The disk space was debridedexhaustively using nonmotorized, hand tools to bleeding subchondralbone. The debrided disk material was measured in a volumetric syringe.Bone Graft (BG) material consisting of silicated tricalcium phosphategranules and hyaluronic acid powder were mixed in a 1:1 ratio and localbone graft and bone marrow aspirate concentrate were added together toform a slurry. The slurry was measured volumetrically. Disk spacemobilization and distraction was carried out with serial impaction ofdistractor tools until appropriate disk height was achieved. Distractionranged from 8 mm to 14 mm, with the 10 mm or 12 mm height being mostcommonly observed.

The BG delivery tool of this disclosure was used to apply the BG slurryto the disk space. The embodiment had a rectangular cross section withthe same footprint as a small fusion cage (8 mm×12 mm). The tapered tipwas placed into the debrided disk space under microscopic control toallow for direct visualization, followed by the application of a snap-onfunnel for loading the BG. The BG slurry was then placed in the funneland the slurry was pushed into the disk space with the plunger. Thebiportal design of the delivery tool directed the slurry into thelateral areas of the prepared disk space, leaving a natural void for thefusion cage once the tool was removed. Once the disk space was filledentirely, the site of insertion was inspected for any BG material, whichmight have escaped the confines of the disk space. This material wasexcluded in the final measurement to ensure an accurate calculation ofBG delivery. Removal of the delivery tool provided an unobscured pathfor the fusion cage to be applied.

A polyether ether ketone, hollow interbody fusion cage of theappropriate size was then placed into the disk space. A minimallyinvasive, bilateral pedicle screw/rod system was applied prior to woundclosure. Average blood loss for the procedures was 127 ml±75 ml.

A two-tailed student's t-test was used to determine if any significantdifference existed between the volumes of disk material removed at L4-5versus L5-S1. The null hypothesis was that no significant differenceexisted between samples. Significance was set at p<0.05. The two-tailedt test was also used to determine whether a significant differenceexisted between volumes of BG delivery and disk material removed. Theformula [(BG delivered+graft volume of the fusion cage)/disk materialremoved] was used to generate the ratio of BG delivery versus diskmaterial removed.

In order to compare the volume of disk material removed during a T-LIFprocedure with a complete, surgical discectomy, the volume of diskmaterial removed during L5-S1 anterior lumbar discectomy was measuredvolumetrically. The L5-S1 disk was harvested and measured for patientsundergoing either anterior fusion or total disk replacement. Thematerial removed consisted of anterior and posterior annulus as well ascomplete nuclectomy, and represented more tissue (in terms of theannuli) than would be typically removed in a T-LIF procedure. There were29 anterior L5-S1 discectomy patients. The age range, genderdistribution and diagnosis were the same as the T-LIF patients.

All study patients were followed up with anterior/posterior radiographsand a physical examination at 4 weeks, 12 weeks, 26 weeks and 52 weekspost-surgery. A visual analog scale (VAS) for pain was obtained at eachvisit and an Oswestry Disability Index (ODI) was completedpreoperatively and at 26 weeks postoperatively.

Results

There were 58 L4-5 disk spaces and 33 L5-S1 disk spaces evaluated. Theaverage volumes of disk material harvested from L4-5 and L5-S1 were 4.1ml±2.2 ml and 2.8 ml±1.9 ml, respectively. The p-value for the student'stwo-tailed t-test was equal to 0.01, revealing a significant differencein terms of disk material removed between L4-5 and L5-S1. The range ofvolume was less than 1 ml to 14.5 ml. The comparison between diskmaterial removed and BG material inserted at L4-5 or at L5-S1demonstrated a significant difference (p<<0.001).

BG volume applied to L4-5 was 9.8 ml±3.3 ml. At L5-S1 it was 8.6 ml±3.2ml. The p-value for the student's two-tailed t-test was equal to 0.07,trending to a significant difference in bone graft applied between L4-5and L5-S1. The combined average was 9.2 ml±3.0 ml. The volume of BGapplied ranged from 4.5 ml to 19 ml. The formula of [(BG delivered+graftvolume of the fusion cage)/disk material removed] generated a surprisingresult: The amount of disk material removed compared to the amount of BGplaced in the disk space was not a 1:1 ratio, as would have beenempirically expected. At L4-5 the ratio was 3.4±2.2 and at L5-S1 it was4.7±2.7, as shown in FIGS. 34A-B, respectively. This was statisticallysignificant with a p-value of 0.02. With respect to the entire study,the ratio of BG inserted relative to disk material removed revealed thaton average 3.7±2.3 times as much BG was inserted into the disk space asdisk material removed. This finding was even more dramatic withcollapsed disk spaces where 1 ml of disk material harvest led to anaverage of 6.6 ml±0.9 ml of BG delivery, as shown in FIGS. 35A-B. Thevolume of BG delivery was asymptotically related to the volume of diskmaterial removed with 12.3 ml of disk material being delivered to a diskwhere 8.0 ml of disk was removed, as shown in FIGS. 35A-B.

The average volume of disk material removed during a T-LIF discectomy atL5-S1 was 3.2 ml and the average volume of disk material from theanterior L5-S1 discectomy was 8.1 ml. Dividing the average T-LIF volumeby the average anterior discectomy (including annuli) volume revealedthat on average 34% of the disk material was removed at the time of 25T-LIF at the L5-S1 disk space.

Because of the tapered tip of the BG delivery tool, it was possible toenter the most collapsed disk space without endplate injury. Thedelivery device did not jam with the application of the BG slurry. Theremovable funnel allowed direct visualization of the tool under themicroscope without obscuring its tip during insertion. Because thedelivery device applied BG out of its side portals, it provided anatural void for fusion cage insertion, and no cage jamming resultedduring impaction. BG delivery using the described tool took a fractionof the time (less than 2 minutes) usually devoted to depositing BG tothe disk space. There were no complications associated with the use ofthe BG delivery tool. The average preoperative ODI measured 29±9 and thepostoperative value was 21±8. A significant difference was not detectedwith p=0.06. The VAS similarly improved with 5 pre-operative scoremeasuring 7.5±1.5 and postoperative score 4.0±2.5. The postoperative VASwas statistically significant relative to the corresponding preoperativevalue with p<0.05. Pseudoarthrosis developed in 7 disks in 4 patients(7.6%). The patients with 2-level pseudoarthrosis had a diagnosis ofhypothyroidism. This diagnosis was also present in one of the singlelevel pseudoarthosis patients. The remaining pseudoarthrosis patientsdid not have discernable risk factors (diabetes, tobacco consumption orobesity).

Discussion

There is substantial variation in fusion rates after T-LIF surgery withpseudoarthrosis rates varying from 23.1% to 2.9%. The reasons for therange of successful arthrodesis vary from surgical technique, includingBG preparation and application, to the way in which a pseudoarthrosis isdiagnosed—direct surgical exploration or by radiographic means. Reasonwould dictate that the volume of BG delivered to a prepared disk spacewould contribute positively to successful arthrodesis with inadequategrafting leading to pseudoarthrosis. Using hand tools and the goal ofdisk space debridement, a conservative estimate of 34% of disk removalwas observed in this study at the L5-S1 level. This substantialdifference represents the different goals of the procedures and providesa baseline for general disk space debridement for T-LIF procedures.

The statistically significant difference between the amount of diskmaterial removed from L4-5 versus L5-S1 correlates with the commonlyobserved radiographic finding of disk height at L4-5 being greater thanthat of L5-S1. Likewise, BG delivery to L4-5 was greater relative to theL5-S1 disk space. Although direct volume of BG insertion was greater inL4-5 relative to L5-S1, the ratio (BG delivered/disk material removed)was higher at L5-S1 (4.7±2.7) than at L4-5 (3.4±2.2). This was astatistically significant difference (p<0.02) and corresponds with themore collapsed disk spaces demonstrating a higher percentage of BGdelivery (see FIGS. 34A-B).

On average, 3.7 times as much bone graft was applied to the debrideddisk space relative to disk material removed. This is explained by thefact that the disk space was collapsed at the time of discectomy, andthen distracted and mobilized during the preparation process to adistracted height. This suggests that relying on an empiric 1:1 ratio ofdisk removal to BG insertion grossly under-fills the disk space andwould be an important contributor to pseudoarthrosis. This is anespecially important consideration in the most collapsed disk spacessince distraction to appropriate height in a non-collapsed disk reducesthe ratio to 8:12.3 (see FIG. 35A) or a 1:1.4 ratio.

The BG slurry used in this study consisted of a mixture of granularmaterial and liquid. This combination of materials does not behave as atypical, Newtonian (incompressible) fluid. A non-Newtonian fluid willexude its fluid component as it is compressed, and the residual granularBG material occludes a conventional, cylindrical BG delivery device.

The BG delivery tool in this study revealed a number of advantages inthat it allowed for BG application in collapsed disc spaces due to itswedged tip, a process which is not possible with round-ended injectioncannulas. The increased cross-sectional footprint relative to a roundcannula allowed considerably less friction of non-Newtonian fluidmaterial through the cannula, resulting in an increase in the BG flowdynamics, and eliminating jamming due to BG impaction. It is estimatedthat changing the cross-sectional area from 8 mm×8 mm to 8 mm×12 mmimproves the flow dynamics of a non-Newtonian fluid by 40%. The twosites for BG extrusion at the sides of the cannula tip double the exitzone surface area, further decreasing the resistance to flow of thegranular mixture. The removable funnel allowed direct visualization ofthe cannula as it was applied to the disk space without being obscuredby the funnel. The biportal expression of the BG material allowed graftinoculation of all prepared areas of the disk space and left a void forthe fusion cage. The applied BG delivery tool allowed refilling of thecannula without having to remove the device, resulting in decreasedpotential trauma to the adjacent nerve tissue.

The fusion rate in this study was 92.4% with three of thepseudoarthrosis patients having a diagnosis of hypothyroidism. This maybe related to abnormalities in bone metabolism associated in patientswith endocrinopathy. The other pseudoarthrosis patients did not haveapparent risk factors. Postoperative pain scores and functionalimprovement correlated with progression to arthrodesis.

In summary, preparation of the disk spaces at L4-S1 can deliver 34% ofthe disk volume during debridement. BG delivery was on average 3.7 timesthe volume of disk removal with a relatively higher ratio of BG beingdelivered to the more collapsed disk spaces. A novel BG delivery devicecan be used to dispense a volume of BG to the disk space that is capableof filling the entire debrided area in an efficient and safe fashion.This should allow for maximization of arthrodesis potential, increasepatient safety, and decrease operative time.

While various embodiment of the present disclosure have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and alterations are withinthe scope and spirit of the present disclosure, as set forth in thefollowing claims.

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the disclosure to the form or forms disclosed herein. In theforegoing Detailed Description for example, various features of thedisclosure are grouped together in one or more embodiments for thepurpose of streamlining the disclosure. This method of disclosure is notto be interpreted as reflecting an intention that the claimed disclosurerequires more features than are expressly recited in each claim. Rather,as the following claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment. Thus, the followingclaims are hereby incorporated into this Detailed Description, with eachclaim standing on its own as a separate preferred embodiment of thedisclosure.

Moreover, though the present disclosure has included description of oneor more embodiments and certain variations and modifications, othervariations and modifications are within the scope of the disclosure,e.g., as may be within the skill and knowledge of those in the art,after understanding the present disclosure. It is intended to obtainrights which include alternative embodiments to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

We claim:
 1. A bone graft material delivery system, comprising: a hollowtube adapted to receive bone graft material, the hollow tube having: aproximal portion; a distal portion with at least one opening therein;and a breech area, interconnected to at least one of the proximalportion and the distal portion via a breech hinge, and configured torotate about the breech hinge between an open position and a closedposition; and a plunger configured for urging bone graft material fromthe proximal portion through the distal portion and outwardly throughthe at least one opening of the distal portion, wherein the proximalportion is securely interconnected to the distal portion along alongitudinal axis of the hollow tube, and wherein, when the breech areais in the open position, an interior volume of the proximal portion isexposed to allow for loading of bone graft material therein.
 2. Thesystem of claim 1, wherein the at least one opening includes twoopenings on lateral sides of the hollow tube.
 3. The system of claim 1,wherein the plunger has teeth formed along a longitudinal axis of theplunger, wherein the system further comprises a pivotally mountedtrigger configured to engage the teeth of the plunger, and wherein thepivotally mounted trigger is operable to advance the plunger toward thedistal end of the hollow tube.
 4. The system of claim 1, wherein thedistal end of the hollow tube is at least partially closed.
 5. Thesystem of claim 1, wherein the hollow interior of the hollow tube has agenerally rectangular cross-section.
 6. The system of claim 1, whereinthe hollow tube is generally linear.
 7. The system of claim 1, furthercomprising a funnel configured to be coupled to the proximal end of thehollow tube.
 8. The system of claim 7, wherein the funnel is configuredto receive bone graft material therein and convey bone graft materialinto the proximal end of the hollow tube.
 9. The system of claim 1,further comprising a fusion cage detachably coupled to the distal end ofthe hollow tube.
 10. The system of claim 1, wherein one or more of thehollow tube and the plunger are printed using a three-dimensionalprinting process, and wherein the three-dimensional printing processcomprises one or more of fused filament fabrication, plaster-basedthree-dimensional printing, selective laser sintering, selective heatsintering, and direct ink writing.
 11. The system of claim 1, furthercomprising a breech lock mechanism, configured to selectively lock thebreech area in the closed position.
 12. The system of claim 11, whereinthe breech lock mechanism is spring-loaded.
 13. The system of claim 1,wherein the proximal portion comprises a vertically extending railconfigured to snugly mate with the breech area when the breech area isin the closed position.
 14. The system of claim 1, wherein the distalportion comprises a knuckle and at least one of the proximal portion andthe breech area comprises a cavity, wherein the knuckle mates with andsnugly fits within the cavity when the breech area is in the closedposition.
 15. A bone graft material delivery system, comprising: ahollow tube adapted to receive bone graft material, the hollow tubehaving: a proximal portion; a distal portion with at least one openingtherein; and a breech area, interconnected to at least one of theproximal portion and the distal portion via a breech hinge, andconfigured to rotate about the breech hinge between an open position anda closed position; and a means for urging bone graft material from theproximal portion through the distal portion and outwardly through the atleast one opening of the distal portion, wherein the proximal portion isinterconnected to the distal portion along a longitudinal axis of thehollow tube, and wherein, when the breech area is in the open position,an interior volume of the proximal portion is exposed to allow forloading of bone graft material therein.
 16. The system of claim 15,wherein the means for urging comprises a plunger.
 17. The system ofclaim 15, further comprising a funnel configured to be coupled to theproximal end of the hollow tube, and wherein the funnel is configured toreceive bone graft material therein and convey bone graft material intothe proximal end of the hollow tube.
 18. The system of claim 15, furthercomprising a spring-loaded breech lock mechanism, configured toselectively lock the breech area in the closed position.
 19. The systemof claim 15, wherein the proximal portion comprises a verticallyextending rail configured to snugly mate with the breech area when thebreech area is in the closed position.
 20. The system of claim 15,wherein the distal portion comprises a knuckle and at least one of theproximal portion and the breech area comprises a cavity, wherein theknuckle mates with and snugly fits within the cavity when the breecharea is in the closed position.